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FDA IMPORT PROCEDURES
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1. | Importer or agent files entry documents with U.S.
Customs Service within five working days of the date of
arrival of a shipment at a port of entry.
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| 2. | FDA is notified of an entry of a regulated food through:
- Duplicate copies of Customs Entry Documents (CF 3461,
CF 3461 ALT, CF 7501 or alternative),
- Copy of commercial invoice, and,
- Surety to cover potential duties, taxes and penalties.
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| 3. |
FDA reviews Importer's Entry Documents
to determine if a physical examination, wharf examination,
sample examination should be made.
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| 4A. |
Decision is made not to collect a sample. FDA sends a "May
Proceed Notice" to U.S. Customs and the importer of record.
The shipment is released as far as FDA is concerned.
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| 4B. |
Decision is made to collect a sample based on:
- Nature of the product,
- FDA priorities, and,
- Past history of the commodity.
FDA sends a "Notice of Sampling" to U.S.
Customs and the importer of record. The shipment must be
held intact pending further notice. A sample will be
collected from the shipment. The importer of record may
move the shipment from the dock to another port or
warehouse (contact U.S. Customs for details).
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| 5. |
FDA obtains a physical sample. The sample is sent to an
FDA District Laboratory for analysis.
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| 6A. |
FDA analysis finds the sample to be in compliance with
requirements. FDA sends a Release Notice
to U.S. Customs and the importer of record.
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| 6B. |
FDA analysis determines that the sample "appears to be in
violation of the FD&C Act and other related Acts." FDA
sends U.S. Customs and the importer of record a Notice of
Detention and Hearing which:
- Specifies the nature of the violation, and,
- Gives the importer of record 10 working days to
introduce testimony as to the admissibility of the
shipment.
The hearing is the importer's only opportunity to present a
defense of the importation and/or to present evidence as to
how the shipment may be made eligible for entry.
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| 7A. |
Consignee, true owner, importer of record, or a designated
representative responds to the Notice of Detention and
Hearing. The response permits the introduction of
testimony, either orally or written, as to the
admissibility of the shipment.
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| 7B. |
Consignee, true owner, importer of record, or a designated
representative neither responds to the Notice of Detention
and Hearing nor requests an extension of the hearing period.
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| 8A. |
FDA conducts a hearing concerning the admissibility of the
product. The hearing is an opportunity to present relevant
matters and is confined to the submission of pertinent
evidence.
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| 8B. |
FDA issues a Notice of Refusal of Admission to the importer of
record. This is the same person or firm who was sent a Notice
of Sampling. All recipients of the Notice of Sampling and the
Notice of Detention and Hearing are sent a copy of the Notice
of Refusal.
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| 9A. |
Importer of record presents evidence indicating that the
product is in compliance. Certified analytical results of
samples, examined by a reliable laboratory and which are
within the published guidelines for levels of contaminants
and defects in food for human use, may be presented.
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| 9B. |
Importer of record submits an Application for Authorization
to Recondition or to Perform Other Action (FDA Form FD 766).
The form requests permission to try to bring a food that is
adulterated or misbranded into compliance by relabeling or
other action, or by converting to a non-food use. A
detailed method to bring the food into compliance must be
given.
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| 9C. |
FDA receives verification of the exportation or destruction
of the shipment from U.S. Customs. The exportation or
destruction of the merchandise listed on the Notice of
Refusal of Admission is carried out under the direction of
U.S. Customs.
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| 10A. |
FDA collects follow-up sample to determine compliance with
guidelines.
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| 10B. |
FDA evaluates the reconditioning procedure proposed by the
importer. A bond is required for payment of liquidated
damages.
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| 11A. |
FDA finds that the sample is "in compliance." A Release
Notice with the statement "Originally Detained and Now Released" is sent to
U.S. Customs and the importer.
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| 11B. |
FDA finds that the sample is not in compliance. The
importer may either submit an Application for Authorization
to Recondition or to Perform Other Action (see 9B), or, FDA
will issue a Notice of Refusal of Admission (see 8B).
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| 11C. |
FDA approves importer's reconditioning procedures. The
approved application contains the statement "Merchandise
Should Be Held Intact Pending the Receipt of FDA's Release
Notice."
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| 11D. |
FDA disapproves applicant's reconditioning procedure if
past experience shows that the proposed method will not
succeed. A second and final request will not be considered
unless it contains meaningful changes in the reconditioning
operation to ensure a reasonable chance of success. The
applicant is informed on FDA Form FD 766.
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| 12. |
Importer completes all reconditioning procedures and advises
FDA that the goods are ready for inspection/sample
collection.
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| 13. |
FDA conducts follow-up inspection/sample collection to
determine compliance with the terms of the reconditioning
authorization.
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| 14A. |
FDA analysis finds that the sample is in compliance. A
Release Notice is sent to the importer and to U.S. Customs.
The charges for FDA supervision are assessed on FDA Form FD 790.
Copies are sent to U.S. Customs which is responsible for obtaining
total payment including any expenses incurred by their personnel.
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| 14B. |
FDA analysis finds that the sample is still not in
compliance. Charges for FDA supervision are assessed on FDA
Form FD 790. Copies are sent to U.S. Customs which is
responsible for obtaining total payment including expenses
incurred by their personnel.
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