Contents

SUBCHAPTER 430 - DOCUMENTATION & CR

430.01 - Authority

Section 703 of the FD&C Act [21 U.S.C. 373] describes FDA's authority to access and copy records of interstate shipment.

430.02 - Objective

For FDA to initiate formal legal action, interstate jurisdiction must be established. Most often, this is done by documenting interstate movement of a product by copying records ("getting the records") of a shipment represented by an Official Sample. However, on occasion, jurisdiction can be fixed on a limited list of articles, e.g., counterfeit drugs, medical devices, oleomargarine, through other means.

430.03 - Policy

Fully document every Official Sample at the time of collection unless instructed otherwise by the program, the assignment or your supervisor. Current agency policy does not require the collection of records of interstate movement for the issuance of a Warning Letter. Also, the FDA Modernization Act expanded the (rebuttable) presumption of interstate commerce for medical devices to all commodities regulated by FDA. Nevertheless, in any situations where you think a formal legal action may occur, make sure you collect copies of interstate records.

The decision to collect copies of records of interstate commerce in situations involving warning letters may be further covered by District policies or situations. As an example, in cases where the records are readily available and the site is located a long distance from an FDA office, it may be better to collect copies of the records at the time the sample is collected. This will ensure FDA has the records in the event a different action is chosen and you will have saved resources in their collection.

Collection Records - Sample Collections are recorded in the Field Accomplishments and Compliance Tracking System (FACTS). Individuals who may be assigned to collect samples should routinely obtain in advance, a supply of FACTS sample numbers, to be used by the collector to identify samples in the field, prior to accessing FACTS to prepare a sample collection record.

430.04 - Responsibility

Document samples in accordance with procedures in this Sub-Chapter being certain the copies of records obtained cover the product sampled.

Do not remove the dealer's only copy of records. Whenever possible, photocopy or mechanically copy records, if duplicates are not available. Reproductions should be reviewed to ensure all relevant information is readable.

It is possible to enhance the clarity of photocopies from poor originals (e.g., second or third carbon copies, copies in blue ink, etc.) by overlaying the "original" document with one or two clear yellow plastic sheets. These clear yellow plastic sheets are available at most stationary stores.

If the above procedure does not enhance the copied document, pen and ink additions should be made. Records copied on FDA forms must be accurate and legible.

If you are documenting a shipper violation at a dealer, it is your responsibility to show the storage conditions did not contribute to the violation. Obtain an affidavit describing handling of the goods after receipt, and any other information which supports the violation.

In cases where the product does not move Interstate but is formulated from I.S. raw materials, government jurisdiction may be established by documenting the I.S. nature of the major raw materials. This is done by linking copies of records for the I.S. raw material with the production of the final product, by affidavit from a knowledgeable and responsible firm official. See IOM Exhibit 430-M.

Note: In the case of imported products which have been released to commerce, documentation of the sample should also include the port of entry and the importer of record to facilitate investigation by the home district if necessary.

430.05 - Sample Records Identification

Copies of all records obtained and attached to the collection record (including those pertaining to the interstate movement of the lot(s)) must be identified with the sample number (including the prefix if appropriate), collection date, and collector's handwritten name or initials. See IOM 451.05.  If a document is more than one page in length, it must be numbered or attached in a manner that will always allow further reviewers to determine if any pages are missing.

If the firm maintains their records on film or electronically, see IOM 527.01.

431 - EVIDENCE REQUIRED

When documenting violative situations, consider whether you have established FDA's jurisdiction, documented interstate commerce, shown a violation, and determined responsibility for the violation. The contemplated legal action determines the extent of documentation. A preponderance of evidence is required to prevail in a civil action, such as a contested seizure, as opposed to a criminal prosecution, which requires evidence establishing guilt beyond a reasonable doubt.

431.01 - Seizure

For a seizure action, FDA must establish jurisdiction over the product, show its interstate movement and document a violation.

Obtain copies of any document proving the article was introduced into or in interstate commerce, or held for sale after shipment in interstate commerce. Collect copies of the best records available, without extensive search or travel. See section 304(a)(1) of the FD&C Act [21 U.S.C. 334].

431.02 - Injunction or Criminal Prosecution

The proof required depends on the violation of Section 301 of the FD&C Act [21 U.S.C. 331].

Introduction Into I.S. - Proof is required showing introduction into interstate commerce on or about a certain day by a specific person of a specific consignment of the article. In addition, delivery for introduction into I.S. requires proof the seller had knowledge the purchaser intended to introduce the article into interstate commerce. See Section 301(a) or (d) of the FD&C Act [21 U.S.C. 331 (a) or (d)].

Adulteration or Misbranding in Interstate Commerce - Proof is required showing that a specific consignment was in interstate commerce and was rendered violative by a specific person on or about a certain date while therein. See Section 301(b) of the FD&C Act [21 U.S.C. 331 (b)].

Receipt in I.S. - Proof is required showing receipt of a violative consignment in interstate commerce on or about a certain date, along with evidence to show specific delivery thereafter by a specific person. It is essential to show the violative condition of the shipment was known to the consignee before the delivery or proffered delivery. Whether it was sold or given away is immaterial. See Section 301(c) of the FD&C Act [21 U.S.C. 331 (c)].

Manufacture Within a Territory - Proof is required of manufacture within any territory by a specific person on or about a certain date. See Section 301(g) of the FD&C Act [21 U.S.C. 331 (g)].

False Guaranty - Proof of the giving on or about a certain date of a specific guaranty and proof of its falsity; usually a specific sale (and delivery) on or about a definite date to the holder of the guaranty. Interstate commerce is not required, except evidence the consignee normally engages in some interstate business. See Section 301(h) of the FD&C Act [21 U.S.C. 331(h)] and 21 CFR 7.13, 201.150 & 701.9.

Dealer Violation - Proof of interstate origin of the article, and proof of a specific manipulation which adulterates or misbrands the article, on or about a certain date by a specific person. See FD&C Act Section 301(k) [21 U.S.C. 331 (k)].

431.03 - Complaint or Injury Samples

Generally samples collected from complainants during investigation of injuries or foodborne out-breaks are investigational in nature and not documented. However, if the nature of the contamination or adulteration is such that regulatory action may be warranted, the interstate nature of the sample should be documented. Affidavits from the consumer, retailer, and wholesaler should be obtained.

At times even though you may not be able to obtain physical portions of the involved item, a Documentary Sample can be collected by photographing the container, contents, labels, codes, etc., and obtaining necessary affidavits and interstate records. See IOM 408 for sample criteria on complaint samples.

During investigations of alleged tampering incidents, complainants must be advised of the provisions of the Federal Anti-Tampering Act (FATA). A general discussion of the FATA, its provisions for investigation, filing of false reports, and tampering can be useful and informative to those individuals.

Prior to concluding your interview of the complainant, obtain a signed affidavit attesting to the circumstances of the complaint. See IOM 975.04.

432 - DOCUMENTING INTERSTATE SHIPMENTS

The minimum set of records ordinarily submitted with a sample will consist of a copy of the invoice covering the sale of the lot to the dealer, the transportation record showing interstate commerce, and an affidavit signed by the dealer, which identifies both the lot sampled and the applicable records. See IOM 430.03 and 430.05.

432.01 - Sales Records

An invoice does not establish interstate commerce and thus federal jurisdiction. It does not prove actual movement. However, it may provide information as to the value of the goods, carrier, date of shipment, etc. and bear a Food and Drug type guarantee. Collect copies of the invoice to show the owner's intent to sell the product and tie other records to the sample. If the invoice covers numerous items, copy entries covering items sampled and indicate omissions by asterisks. Copy the invoice on the FDA 1662. See IOM Exhibit 430-A. If the invoice bears a Food & Drug guarantee, copy the guarantee on the back of the FDA 1662. Other records which may be substituted in the absence of an invoice are copies of purchase orders, receiving records, canceled checks, correspondence, etc.

Invoices covering in-transit shipments usually are not available. Document any available transportation record that establishes the lot to be in interstate commerce. Be sure to name the shipper and consignee if known. Where positive identification of a shipment cannot be made by personal observation, obtain a statement from the carrier's agent identifying the shipment sampled as having been delivered by the consignor on a certain day for delivery to the consignee. Include in this statement reference to the particular transportation record covering the shipment. The transportation record will generally be available after the shipment is delivered.

Where the sample is taken from a vehicle or dock as the vehicle is loaded, and there are no unusual circumstances which must be explained in a regular affidavit, use the FDA 1664b, Affidavit (In-Transit Sampling). See IOM Exhibit 430-L.

432.02 - Transportation Records for Common Carrier Shipments

Mandatory Access to Interstate Records - Section 703 of the FD&C Act [21 USC 373] provides for mandatory access to and copying of all records showing interstate movement of commodities subject to the Act. This is provided the request is in writing, and the records are in the possession of common carriers, or persons receiving or holding such commodities.

Section 704(a) of the FD&C Act [21 USC 374(a)] provides mandatory access, upon presenting your credentials and issuing a written notice of inspection, to documents covering the interstate movement of, non-prescription drugs for human use, prescription drugs and restricted devices. The authority applies to inspection of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs for human use, or restricted devices are manufactured, processed, packed or held.

Note : At times, you may have only the name of the carrier (trucking company), with no address or phone number. If you are unable to locate the trucking company, contact the local office of the Office of Motor Carrier Safety, Federal Highway Administration, Department of Transportation. If you furnish this office the name of the trucking company, they will be able to provide the address and phone number. The DIB has the phone number of the local offices of the OMCS as part of a MOU between DOT and FDA.

Refusal to Permit Access to Records in Possession of Common Carriers - Refusal to permit access to and copying of all records showing interstate movement of articles subject to FDA jurisdiction is unlawful provided the request for such permission is issued in writing. You cannot state that the law requires the records be furnished to FDA unless you also explain it is required only after a written request is issued. If refused, after providing a written request, politely explain the law requires the records to be furnished. You are more likely to get the records through courteous persuasion and tact than through stressing the force of law.

Written Request for Records - If a carrier, consignee, or any other person refuses to supply I.S. records, and it is apparent he will not do so without a written request, report the facts to your supervisor. Do not routinely issue a written request for I.S. records since evidence so obtained may not be used in the criminal prosecution of the person from whom obtained.

If the request is being made of a carrier who has no responsibility for the violation, issue a written request only after approval by District Management. When authorized by your supervisor to issue a written request, prepare a statement, using the following guidance, or as otherwise directed by your supervisor:

"Pursuant to Section 703 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 373) permission is hereby requested for access to and copying of all records showing quantity, shipper, and consignee, showing movement in interstate commerce and/ or the holding after interstate movement of___________."

Clearly identify the specific lots which are the subject of the request, the firm and the individual to whom the request is given.

Bill of Lading - The shipper who delivers the goods to the carrier for shipment, prepares The Bill of Lading. It is an order for the carrier to move the goods. When the carrier's agent signs the Bill of Lading he acknowledges receipt for the shipment. The carrier's office in city of origin of shipment maintains a copy of the Bill of Lading. Information normally included is the name and address of shipper, name and address of consignee, date of shipment, name of carrier, vehicle number, and a description of the goods. Copy Bill of Lading on Section II of the FDA 1662. See IOM Exhibit 430-A.

Freight Bill - This record is prepared by the transportation company for the purpose of collecting freight charges. It includes the same information found on the Bill of Lading, plus additional data about the carrier's handling of the shipment and cost involved. Railroads prepare Freight Bills at their destination offices, where copies can be made. Steamship and airlines combine the Bill of Lading and Freight Bill into one form. Copies are filed at both origin and destination offices of these carriers. Truck lines prepare Freight Bills at the origin office and both origin and destination offices should have copies. The dealer should have a Freight Bill if he received the goods directly in interstate commerce.

Copy Freight Bills on Section II of the FDA 1662. Enter the type of shipping record in block 21. Section I and II may be executed together on one sheet. If only one section is used, leave the other section blank, and submit the entire page.

Waybill - The transportation company uses the Waybill in its own operations, and it accompanies the shipment during transit. Copies are not given to the shipper or consignee, but can be obtained from the carrier. Other transportation records are generally more readily available than Waybills. Air Freight Waybill numbers are designed so that the originating line and point of origin are encoded in the Waybill number itself. Each airline has a numerical code description, indicated by the first two digits of the number. The three letters, which next follow indicate the point of origin. For example, Waybill No. 01LGA, designates American Airlines (01) as the carrier, and La Guardia Field (LGA) as the point of origin. Most airline offices have a copy of "Official Air Freight Transmittal Manual", which lists the codes. Other express shipping companies, such as Federal Express, and United Parcel Service have their own codes.

Copy Waybills on the FDA 1662.

432.03 - Mail or Parcel Service Shipments.

Always attempt to collect the original wrappings showing cancellation of origin office and address sticker. Record the facts obtained from the dealer on the FDA 463, Affidavit (Parcel Post/Service). Before the individual signs the statement he should be asked to affirm he affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. See IOM Exhibit 430-B.

Note: Shipments made by "Express Mail" do have a shipping record maintained. These are:

1. Express Mail - Form A - used for Post Office to Post Office service.

2. Express Mail - Form B - used for Post Office to Addressee service.

3. Express Mail - Form C - used for Airport to Airport service.

Obtain copies of the Postal Service record from the consignee, if possible, or from the Post Office to document shipments using Express Mail Service.

432.04 - Shipment by Privately-Owned Conveyance

Obtain on the FDA 463a, Affidavit, a dealer's statement setting forth the facts, including the date and manner of receipt. The affidavit by the dealer may not be evidence, since the dealer lacks personal knowledge of the point of origin. Ascertain the name and home address of the driver of the conveyance, vehicle license number, the name and address of the driver's employer or the owner of the conveyance and the driver's license number. Obtain an Affidavit, from the driver setting forth the facts of the shipment. See IOM Exhibit 430-D.

432.05 - In-Transit Sampling Affidavit

See IOM 405.03 and 424 for definition and sampling procedures. When obtaining samples from in-transit lots, if it is a straightforward uncomplicated sample requiring no unusual explanations, use the FDA 1664b, Affidavit (In-Transit Sampling). See IOM Exhibit 430-L. Otherwise, use the regular Affidavit, FDA 463a.

433 - AFFIDAVITS

Statements on various affidavit forms may be obtained from persons who have dealt somehow with the goods sampled, know material facts relating to the movement of the goods, and/or to events affecting their condition. Such facts, recorded in writing and signed by the person who can testify in court to those facts, can be used either to establish federal jurisdiction or fix the responsibility for a violation. The statement may identify documents proving I.S. movement of goods sampled; it may name the person who could testify to the identity of the goods sampled, and it may certify the sample collected is from the lot of goods covered by the records.

General considerations for all affidavits

You should have the affiant read the statement and make necessary corrections before signing the affidavit. Mistakes, corrected, initialed and numbered by the affiant are an indication he/she has read and understood the statement. A handwritten statement by the affiant, declaring he/she read and understood the statement is a valuable tool to counter the possibility the affiant might later claim ignorance of what was signed.

Before the individual signs the statement, ask him/her to affirm the affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. See IOM Exhibit 430-C.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Subscribed and sworn to before me at ***" Subscribed , in this context means to attest by signing. Thus, your signature is attesting to the fact that the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. If you provide a copy of the affidavit to the affiant, you should keep the original affidavit since the original is an official FDA document.

Refusal to Sign the Affidavit - Even if it is apparent the affiant will refuse to sign a statement setting forth the facts he/she has revealed, the statement should be prepared as described above. Either read the statement to the affiant or have him/her read it. Request the affiant to correct and initial any errors in his/her own handwriting. Elicit from him/her an acknowledgement the statement is true and correct. Ask him/her to write at bottom of the statement "I have read this statement and it is true, but I am not signing it because..." in his/her own handwriting. Failing that, declare at the bottom of the affidavit that you recorded the facts above as the affiant revealed them, that the affiant read the statement, and avowed the statement to be true. Sign and date the statement in the body of the document; only sign in the signature block if the affiant signs the affidavit.

Confidential Informants - You should take special precautions when obtaining an affidavit from a confidential informant, the affiant may be reluctant to sign a statement, which reveals his or her identity. See IOM 518 for guidance on interviewing confidential informants.

433.01 - Affidavit (Dealer/Warehouseman)

The Affidavit (Dealer/Warehouseman), FDA 1664, is used to document the dealer or warehouseman identification of the lot and related records. See IOM Exhibit 430-E.

Fill in all blanks on the form as applicable. There are sufficient blanks for listing up to three invoices and up to three shipping records covering the lot in question. Any unused blanks should be lined out, and strike out the words or letters in parentheses which are not applicable.

Be certain the dealer knows what he is signing. Before the individual signs the statement, he/she should be asked to affirm the affidavit is true and accurate.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Subscribed and sworn to before me at ***" Subscribed, in this context means to attest by signing. Thus, your signature is attesting to the fact the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. Also see IOM 433.02 for conditions not amenable to use of the FDA 1664.

433.02 - Affidavit (FDA 463a)

Unusual sampling situations may present circumstances that do not lend themselves to presentation on the FDA 1664 or 1664b. In these situations, record the facts on an FDA 463a, Affidavit.

Preparation - There is no prescribed format for composing the statement. However, you should positively identify the affiant by name, title, and address at the beginning of the statement and show why he/she is qualified to make the statement. The facts should be arranged in an order roughly paralleling that of the FDA 1664. The most manageable narrative describes the events and circumstances chronologically. Whatever format is used, the recorded facts must be intelligible to the reader unfamiliar with the transaction. See IOM Exhibit 430-C, 430-G, and 430-M.

Ascertain all the facts and record those which are material, relevant, and to which the affiant can affirm.

Narrate the facts in the words of the affiant, using the first person singular. Do not use stilted terms such as, "that" as in the expression " that I am the president of.." If the statement is long and complex, break it down into logical paragraphs.

Have the affiant read the statement and make necessary corrections before signing the affidavit. Mistakes that have been corrected and initialed and numbered by the affiant are an indication he/she has read and understood the statement. A handwritten statement by the affiant declaring he/she read and understood the statement is a tool to counter the possibility the affiant might later claim ignorance of what was signed.

Before the individual signs the statement, he/she should be asked to affirm the affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. You should sign and date the statement in the body of the affidavit. Only sign in the signature block if the affiant signs the affidavit. See IOM Exhibit 430-C.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Subscribed and sworn to before me at ***" Subscribed , in this context means to attest by signing. Thus, your signature is attesting to the fact that the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. You and the affiant should sign all pages of a multi-page affidavit.

Refusal to Sign - Even if it is apparent the dealer will refuse to sign a statement setting forth the facts he/she has revealed, the statement should be prepared as described above. Either read the statement to the dealer or have him/her read it. Request the dealer to correct and initial by his/her own hand any errors. Elicit from him/her an acknowledgement the statement is true and correct. Ask him/her to write in his/her own hand at bottom of the statement "I have read this statement and it is true, but I am not signing it because...". Failing that, declare at the bottom of the affidavit that you recorded the facts above as the dealer revealed them, that the dealer read the statement, and avowed the statement to be true.

Be aware, in situations involving confidential informants, the affiant may be reluctant to sign a statement, which reveals his or her identity. See IOM 518 for guidance on interviewing confidential informants.

433.03 - Affidavit (Jobber)

Form FDA 1664a is used to document movement of goods from a jobber to a dealer. See IOM Exhibit 430-F. Complete all blanks as applicable. There are sufficient blanks to list up to three invoices and three shipping records. Line out any unused blanks and strike out all words and letters in parentheses, which are not applicable.

Be sure the jobber knows what he/she is signing. Before the individual signs, he/she should be asked to affirm the affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. You should sign and date the statement in the body of the affidavit. Only sign in the signature block if the affiant signs the affidavit. See IOM Exhibit 430-C.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Subscribed and sworn to before me at ***" Subscribed, in this context means to attest by signing. Thus, your signature is attesting to the fact that the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. If more than one FDA employee is present, they may also sign the affidavit. The dealer may be provided a copy of an affidavit if he/she requests it and it has been signed.

See IOM Exhibit 430-F.

435 - LABELS AND LABELING

No sample documentation is complete without copies of the label and labeling. No special effort is needed to obtain copies of the label when it is on the individual units collected. However, the goods may be accompanied by labeling which is not affixed to the product. In this case, you must obtain copies of all labeling. Although your sample assignment may not specifically request the collection of accompanying labeling, determine if such labeling exists, and if it is present, collect it.

Collect at least three copies of all labeling. When you are collecting labeling specifically to document labeling violations, the Compliance Program Guidance Manual may require the collection of additional copies so that various offices can review the labeling simultaneously (for example, CPGM 7321.005 requires the investigator collect 4 copies). Be sure to review the CPGM to ensure you collect enough original copies of labeling.Mount individual copies or sets of labeling so they can be reviewed by various individuals located in separate offices. Do not collect the actual labeling if only one copy is available. To do so may remove the offending literature and thus correct the misbranding or you may misbrand the product yourself, by removing legally mandated information. Photographs or other copies must be made in this case.

435.01 - Labels & Accompanying Labeling

These are defined as:

1. Label - A display of written, printed, or graphic matter upon the immediate container of an article.
2. Labeling - All labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. Labeling includes such material as circulars, booklets, placards, displays, window streamers, books, article reprints, etc., that supplement or explain a product and /or are part of an integrated distribution system for the product. If the labeling and the product are in functional proximity at a point of sale, provide diagrams or photographs of this relationship. If the labeling and the product are found at a manufacturer or distributor, document the role that the labeling will play in the distribution of the product (e.g. to whom will it be sent and when).

Dealer Identification - Request the dealer (Note: a manufacturer may be considered a dealer if the product being sampled is located at the manufacturer) identify collected copies of accompanying labeling with his initials and the date. This will identify these copies of labeling if they are introduced in court later. Prepare a dealer's affidavit on the FDA 463a, covering the relationship of the labeling to the goods. This affidavit should include the following information.

1. Description of Labeling - Describe briefly each piece of literature by name of identifiable quote, i.e., Leaflet, "Do You Have Tired Blood" or Window Streamer, "Amazing New Tranquilizer". State the quantity of such labeling on hand.
2. Location of Labeling - Report the location of each different piece of literature and how much of each is at that location.
3. Method of Distribution - Determine how the labeling is made available to the public. Describe how it is displayed such as: for voluntary pick-up; mailed to prospective customers; distributed without being displayed, etc.
4. Source of Labeling - Describe whether the labeling was sent to the dealer by the shipper of the goods or if the dealer prepared the labeling himself or if it originated from another source. It is important to document this point to fix responsibility in the event the agency wishes to pursue action against that individual. It is not necessary to determine or fix responsibility in order to seize the goods. Document the shipment of the labeling if a source other than the dealer supplied the labeling.
5. Instructions to Dealer - The manufacturer or shipper often provide sales promotion instructions to the dealer. Obtain copies of such instructions if available.

435.02 - Bulk Shipments

Do not remove the label from bulk containers such as drums, barrels, and large bags, if this results in misbranding the article. Remove and submit an identical label from an empty container if available. Photograph or trace the label if none other is available.

Note: Besides using tracing paper, it is possible to trace a label on a piece of plastic, similar to a document protector, using either a ball point pen or stylus. If it is difficult to read, filling in the tracing with a marker, may highlight the tracing.

435.03 - Unlabeled or Partially Labeled Lot

The regulations provide for controlled shipment in IS commerce of unlabeled goods. It is a violation to ship unlabeled goods unless:

1. The shipper operates the establishment where the article is to be processed, labeled or repacked, or
2. If the shipper is not the operator of the establishment, he must first obtain from the owner a written agreement signed by the operator. The agreement must contain the post office addresses of both parties and describe the specifications and the processing, labeling, or repacking procedures, in sufficient detail to insure that the article will not be adulterated or misbranded within the meaning of the Act, upon completion of the processing, labeling or repacking.

Determine if there is a labeling agreement and obtain copies of pertinent correspondence. See 21 CFR 101.100, 201.150, and 701.9.
Documentation - Collect both unlabeled and relabeled units or specimens of the label to be affixed. Collect specimens of any shipping case labels and any labeling which accompanied the original shipment.
Obtain evidence showing how the lot was labeled at the time of receipt; how the misbranding occurred, and who was responsible. Use photographs and diagrams if necessary to portray the present condition of the lot. If any of the lot has been resold, collect documentary evidence of the resale.