Contents

SUBCHAPTER 620 - REVIEW OF RECORDS

620 - GENERAL

"Records review" is the initial examination provided the importer's documentation (including any electronic entry filing information.) Also, see IOM 530.04 for Food and Cosmetics Defense Inspection Activities. This operation is performed on every entry of regulated product to determine if additional action, such as sampling, is necessary. (Review of electronic filings follows the same decision-making criteria applied to hard-copy entry filings.) At this point, one of four decisions is made:

1. Release the lot, or
2. Detain the lot, or
3. Examine the lot by Field Examination, or Sampling, or
4. Verify registration, listing, declarations, certifications, etc. where applicable.

The decision will be supported by:

1. Electronic screening on entry information,
2. Computerized information (FIARS, local/regional data systems),
3. Import Alerts,
4. Monthly Refusals List,
5. Past history,
6. Compliance Program Guidance Manual,
7. Assignments, and
8. Local assignments and programs (e.g., Regional Pesticide Sampling Plan).

See Regulatory Procedure Manual (RPM) Chapter 9 for additional guidance concerning the review/processing of entries of specific types of commodities, including products under detention without physical examination.

Record reviews are reported into PODS as Entry Reviews.

SUBCHAPTER 630 - FIELD EXAMINATION

630 - GENERAL

A field examination is simply an on-the-spot examination or field test performed on a product to support a specific decision. It may be conducted on products discharged from vessels on to the wharves (piers), pier sheds, and other locations; products in trucks, trains, freezers, and containers, etc., at border entry points; or on products set aside for FDA examination. Some compliance program guidance manuals do not address field examinations. Nevertheless, field examinations are appropriate for certain problems and/or commodities and should be conducted.

A field examination involves actual physical examination of the product for such things as storage or intransit damage, inadequate refrigeration, rodent or insect activity, lead in dinnerware (Quick Color Test - QCT), odor and label compliance

A field examination does not have the same level of confidence as a laboratory examination. Consequently, more rigorous standards of acceptance are applied than those used for formal regulatory levels. For example, if the formal action guideline for whole insects is 10 per 100 gms in product X, you may sample product X when your field examination shows only one or two insects per 100 gms. The decision to sample is, to some degree, left to your discretion. In most instances, it should be based on findings significantly lower than specified by the formal guideline.

A field examination begins when the physical examination is started. Do not include, as reported Field Examination time, the time to locate the lot or travel time. Time spent in locating the lot is reported as import investigation.

See IOM 504.03 for suggestions on what to do when conducting a field examination and the firm responsible for the products invites individuals who are not directly employed by the firm to observe the examination.

631 - FIELD EXAMINATION SCHEDULE

A Field Examination should include a physical examination of a minimum of five containers (cases, cans, bags, etc.) of a product, or as directed by Compliance Program Guidance Manuals, specific product examination schedules (e.g., LACF), or other guidance.

When you conduct any field examination of a product's label or labeling, in addition to the specific items discussed in the following sections, be alert for any overlabeling where a product name or identify may have been changed; products without mandatory English labeling; changes in expiration date or lot numbers or similar questionable practices. If you encounter any of these items, collect an example and discuss the appropriate action with your supervisor.

632 - FIELD EXAMINATIONS - FOODS

See IOM 530.04 for guidance on performing reconciliation examinations during import field examinations.

632.01 - Food Sanitation

Microbiological - field examinations can not be used for suspected microbiological contamination.

Filth & Foreign Objects - field examine only those product/container combinations in which you can physically view and examine the product, e.g., products which can be probed, products in see-through containers, etc. See IOM 429 and 505, et al for some specific guidance on performing field examinations.

Low acid and other Canned Foods - See IOM SAMPLE SCHEDULE CHART 2.

Decomposition in Non-sealed Foods - This can include organoleptic examination for fish, seafood, frozen eggs, etc.

632.02 - Pesticides, Industrial Chemicals, Aflatoxins, & Toxic Elements Aflatoxins, & Toxic Elements

Field examinations can not be performed for most of these materials, except for metals in dinnerware. 

NOTE: Districts should use commercial versions of the Quick Color Test (QCT) and the Rapid Abrasion Test for lead, e.g. Lead Check Swabs, for the field examination of dinnerware and food cans to determine if follow-up sampling is required.  The testing scheme for dinnerware can be found in CPGM 7304.019B. 

632.03 - Food and Color Additives

The only valid field examination which can be performed for these materials is a visual examination through the container and a label review for the mandatory labeling requirements, i.e., is a color additive declared for a product without natural coloring; determining if an additive declaration includes its function, for example, "Sodium Benzoate as a preservative".

NOTE: Label examination of products to determine whether there is a declaration of certain food and/or color additives must be reported as an import investigation.

632.04 - Nutrition and Nutrition Labeling

The only valid field examination which can be performed for this type of problem is a label examination for the mandatory labeling requirements. See the "Guide to Nutritional Labeling and Education Act (NLEA) Requirements" document.

632.05 - Food Economics (On consumer size containers only)

Label Examination - Review labels for all aspects of the labeling requirements.

Net contents - See IOM 428.01

Food Standards - The only valid field examination which can be performed for Food Standards is a label examination for the mandatory labeling requirements of a particular Food Standard.

NOTE: Label examinations of products to determine if the labeling meets the mandatory labeling requirements for a particular Food Standard must be reported as an Import Investigation. a name="632.06">

632.06 - Cosmetics

The only valid field examination which can be performed for these products is a label examination for the mandatory labeling requirements. The most important are:

1. Ingredient Labeling (21 CFR 701.3),
2. Prohibited ingredients (21 CFR 700.11 through 700.23 and 250.250),
3. Non-permitted color additives,
4. Warning Statements (21 CFR 740.11 and 740.12) (Prohibited fully halogenated chloroflurocarbon propellants).

NOTE: Label examinations of products to determine whether their labeling declares certain ingredients must be reported as an Import Investigation.

633 - FIELD EXAMINATION - DRUGS

When you conduct field examinations of drugs (bulk drugs and finished dosage forms) ensure you check:

1. Labeling compliance (e.g., Reye Syndrome warning)
2. Probable contamination
3. Tamper Resistant Packaging Requirements

633.01 - Labeling

The only valid field examination which can be performed for these products is a label examination for the mandatory labeling requirements. The most important are:

1. Ingredient Labeling (21 CFR 701.3),
2. Prohibited ingredients (21 CFR 700.11 through 700.23 and 250.250),
3. Non-permitted color additives,
4. Warning Statements (21 CFR 740.11 and 740.12) (Prohibited fully halogenated chloroflurocarbon propellants).

NOTE: Label examinations of products to determine whether their labeling declares certain ingredients must be reported as an Import Investigation.

When you conduct field examinations of drugs (bulk drugs and finished dosage forms) ensure you check:

1. Labeling compliance (e.g., Reye Syndrome warning)
2. Probable contamination
3. Tamper Resistant Packaging Requirements

Bulk drugs and finished dosage forms should be evaluated for compliance with the Drug Listing Act, 21 CFR 207.40. Refer to the Drug Listing Compliance Program Guidance Manual.

633.02 - Contamination

Drugs should be examined for container integrity, e.g.: cracked vials, ampoules, bottles, etc.

633.03 - Samples

A decision to collect samples for Drug Listing Act compliance evaluation should be made in accordance with the drug listing CPGM. The nature of samples to be taken from lots where the drug substance or finished product has been subjected to actual or suspected contamination, should be decided on a case-by-case basis.

633.04 - Special Instructions

Field examinations may be made of drug lots to obtain information in determining the new drug status of a given shipment. Districts should contact the Division of Labeling and Non-Rx Drug Compliance, Import/Export International Drug Team, (HFD-316) for guidance.

634 - FIELD EXAMINATIONS - DEVICES

Medical device field exams include electrode lead wires, patient cables, labeling, and physical damage. Lead wires and patient cable exams should conform to applicable standards set forth in 21CFR Part 898.

635 - FIELD EXAMINATIONS - BIOLOGICS

Medical device field exams include electrode lead wires, patient cables, labeling, and physical damage. Lead wires and patient cable exams should conform to applicable standards set forth in 21CFR Part 898.

Review the biologics section of Chapter 9 of the RPM and the Import Alert regarding biologics prior to conducting any field examinations of biological products.

In general, products controlled by Center for Biologics Evaluation and Research (CBER) do not require field examination, because they are licensed under Section 351 of the PHS Act. In addition, lot release procedures pursuant to 21 CFR 610.2 apply to many products, such as vaccines.

Products imported under IND Applications are also monitored, but due to the small volumes involved, no specific guidance is necessary.

Shipments of biologics which are not licensed, or are not directly related to an active IND should be examined for:

1. Labeling
2. Consignee
3. Manufacturer
4. Intended use

Contact CBER/OC/Division of Case Management (HFM-610) for guidance.

636 - FIELD EXAMINATIONS - VETERINARY PRODUCTS

Field examinations of veterinary drugs are visual examinations to determine potential misbranding or adulteration. This may include examination for: (1) Container Integrity, (2) Labeling Compliance, and (3) Product adulteration. Dosage form drugs must be examined to determine if they are new animal drugs. If the products are new animal drugs, you need to determine if an approved NADA/ANADA exists or if there is a valid INAD exemption in place. You should consult with CVM's Division of Compliance (HFV-230) regarding the status of imported veterinary products (301-827-1168).

Bulk New Animal Drug substances and Active Pharmaceutical Ingredients (APIs) may be legally imported only if destined to the holder of an approved NADA or INAD exemption. You will need to consult with the Center for the status of particular drugs.

Entries of prescription animal drugs for use by the consumers (laymen) must be examined for labeling content, consignee (name and address) and to determine if a valid prescription/order exists from an appropriately licensed veterinarian. The Center (301-827-1168) should have records of any exemptions or permission granted for personal imports.

Devices intended for animal do not require premarket approval. However, they are still subject to examinations for misbranding violations. Animal devices must bear adequate directions for use and label claims must not be false or misleading. You should consult with CVM for guidance (301-827-1168).

Animal feeds and feed components, including pet foods should be examined for conformance with all applicable and appropriate food labeling requirements, drug claims, food additive violations and use of banned or objectionable ingredients as well as filth and foreign objects. You should consult with CVM on individual issues and to determine specific requirements (301-827-1168).

Cosmetics for animals are referred to as "animal grooming aids". While the Center does not actively pursue enforcement actions with animal grooming aids, the products are expected to be safe, effective and properly labeled. The labels and labeling of any incoming animal grooming aids are subject to examination and review for potential instances of misbranding. Consult with the Center for appropriate guidance. The Division of Compliance (301-827-1168) can answer regulatory and enforcement questions. The Division of Surveillance (301-827-0158) tracks reporting of complaints and adverse reactions, including those for animal grooming aides.

CVM does regulate animal biologic products. They are considered as drugs. However, the Center does not regulate animal vaccines. The vaccines are regulated by USDA/APHIS.

Contact the CVM Division of Compliance (HFV-230), the Enforcement and Regulatory Policy Team, with general questions on the importation of veterinary products. You should be aware of various Import Alerts, Compliance Policy Guides or Guidance Documents as they affect individual import situations. See the CVM website for additional information or notifications on current import situations

637 - FIELD EXAMINATIONS RADIOLOGICAL HEALTH

Field Examinations for imported electronic products consist of reviewing the Entry Documents and FDA-2877, Declaration for Products Subject to Radiation Control Standards, to determine if they are properly completed and accurate. This applies to each shipment of electronic products for which performance standards exist. Performance standards, covering ionizing, optical, microwave and acoustic radiation-emitting products, are specified in 21 CFR 1020 through 1050.

For electronic products, physical samples may only be collected on specific assignment. DTR/DER recommendations are to be submitted when the Field Examination indicates the product may not be in compliance and detention is recommended.

Import coverage for radiation emitting products is provided for in a CDRH Compliance Program Guidance Manual. Do not collect physical samples except on specific assignment, or with concurrence of CDRH.

SUBCHAPTER 640 - IMPORT SAMPLE COLLECTION

641 - GENERAL

In general, the difference between Official Domestic and Import Samples is that import samples do not require official seals or collection of a 702(b) reserve portion. However, these are district options. There will be instances when the collection of a reserve portion and an official seal is warranted, i.e., when enforcement action (e.g., seizure, injunction, prosecution) is contemplated. Many sample sizes are provided in the Sample Schedule Section (Chapter 4). When using the sample sizes furnished elsewhere in this manual, do not collect the duplicate portion of the sample unless directed by your district. In addition, when preparing to collect import samples, you should be aware of your personal safety. Refer to IOM 510.01.

FDA does not pay for import samples at the time of collection. The Importer should be told to bill the responsible district. FDA will not pay for violative import samples, per 21 CFR Part 1.91 See IOM 614.05.

When collecting IMPORT "ADDITIONAL Samples", the original Import C.R. Number should be used. Under OASIS, this will be the entry number with appropriate line information, etc.

Import Samples are compliance samples, except for those collected for pesticide analysis. These MUST BE FLAGGED either "Pesticide Surveillance" or "Pesticide Compliance" depending on the basis for sampling. See IOM Sample Schedule Chart 3 (Chapter 4) for guidance.

642 - PROCEDURES

Review the submitted entry (electronic or hard copy documentation) to assure the location of the product(s) is known and the lots are available for FDA examination/ sampling before initiating action. The general description of the shipment in the entry documentation submitted to FDA should match the description of the product(s) in the invoice from the broker.

643 - TECHNIQUES

Follow guidance furnished in IOM SubChapter 420 - Collection Technique.

644 - IMPORT FORMS PROCEDURES

Because forms are now generated electronically by OASIS, individuals performing field examination or sample collections should follow guidance provided in the OASIS Training Manual, or consult their lead OASIS personnel.

645 - SAMPLE COLLECTION REPORTS

See IOM 100 English language requirement. For every sample collected, a corresponding electronic collection report must be completed in OASIS. (See IOM Exhibit 640-A.) You are responsible for making sure the date collected, quantity collected, unit of weight, and description of text fields are completed accurately. The following are instructions for completing an OASIS Collection Report:

• Highlight the line sampled in your available work personal in box in OASIS or self assign the sample request.
• Prior to entering any data, double check all entered data for accuracy.
• Double click the work type, i.e. “SAM” and click the ”line Details” button. The line details screen is the only place you can make corrections to the entered data.
• Verify all data is correct, i.e., product code matches actual product, manufacturer, country of origin, quantity & value are correct. If there is a build button on the line you need to correct, you must use the build function to make corrections. Once data has been changed, click on save button; enter brief description in pop up box of corrections made.
• Click on “Rescreen” in the Application Tool bar to see if changing any data caused the line to hit on any other criteria or alerts.
• Highlight the line sampled and click on “Wk Detail” in the Application Toolbar.
• Click to highlight the appropriate PAFs in the bottom area of the screen. If you are sending the sample to more than one laboratory, highlight the PAF for each laboratory individually and complete a separate collection report for each lab.
• Click “Work Result” button near the top right of the screen.

OASIS completes the following fields for you. Entry number, Investigator initials, Date Collected, Product Code, Product Code Description, Importers Corrected Description, Location of Goods, default laboratory in Submitted To and the FACTS Lab Number. The Date Collected, Location Of Goods and Submitted To fields can be corrected on this screen.

Enter data in the following fields:

Collection Date: Make sure the date reflects the date the sample was actually collected, not the date you are entering the sample in OASIS.

Episode: An "episode" is defined as a violative pesticide (or other chemical contaminant) finding and all samples collected in follow-up to that finding. All samples must be associated with one responsible firm (grower, pesticide applicator, etc.) and one specific time period (e.g. growing season). For example, samples of cantaloupes from Mexico reveal violative residues. Any destination point samples or subsequent compliance samples from the same shipper or grower would along with the original sample be considered an episode. Enter the episode number.

Submitted To: Select the appropriate lab from the pull-down menu. The default will be your district servicing laboratory for the type of analysis. It can be changed if necessary.

Quantity Collected: Enter the number of sampled units you collected.

Units: Select the appropriate units from the pull-down menu. If the appropriate unit does not appear on the menu, go back to the line detail screen and correct the units before you complete the collection report. Note: at this point a new lab number will be assigned when you return to your collection report screen.

Desc Text: Enter a description of the sample. Be guided by your District policy on how you enter the description. Any text you enter in this field will be printed on the Notice of FDA Action. Describe how you collected the sample. Relate the number and size of the sampled units to show how each was taken and note any special sampling techniques used.

Hand Ship: This field does not transfer to FACTS for the laboratory to view. If special handling instructions are needed, enter them in Remarks. Enter the method of shipping, collecting district, country of origin, collector’s name and phone number.

Remarks: Enter any information your District, Laboratory, or the compliance program requires. Make sure you review the entire screen before you click “OK”. The sample will be transferred immediately in FACTS to the respective lab once the OK button is clicked. (Unless your supervisor has set up a supervisory review of your work)

• The Record Time Screen will appear. Enter your time. If more than one person worked on the sample, click on “add” button to the right. A box will come up; enter the person’s initials & the tab key. Highlight the person’s name, click on OK. Enter other person’s time. Repeat for each person that worked on the sample. Click on OK Note: time is entered in decimal format for OASIS.

SUBCHAPTER 650 - FILER EVALUATIONS

651 - GENERAL

Since we now handle the majority of entries utilizing the OASIS system, evaluation of the data submitted by the electronic filers is done on a periodic basis. These audits of submitted data are done on a periodic basis depending on the number of entries, quality of the data and other factors. You should follow DIOP policy in the conduct of these evaluations.

 

Page Top Previous Page | Document TOC | Chapter TOC | Next Page