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Updated: 2008-02-06
Contents
6.1 - IMPORTS
6.1.1 - AUTHORITY
6.1.2 - IMPORT INVESTIGATIONS
6.1 - IMPORTS
6.1.1 - AUTHORITY
Section 801 of the FD&C Act [21 U.S.C. 381] authorizes FDA examination of foods, drugs, cosmetics and devices offered for entry into the United States. Section 536 of the FD&C Act [21 U.S.C. 360mm] authorizes refusal of radiation emitting products which fail to comply with the requirements of Section 534 (h) of the FD&C Act [21 U.S.C. 360kk (h)]. 19 CFR 151.4 of the U.S. Customs regulations authorizes employees of FDA to examine or take samples of entry merchandise released under immediate delivery.
The procedures outlined in this chapter cover imported merchandise subject to, but not limited to, the following Acts/Regulations:
- Federal Food, Drug, and Cosmetic Act
- Fair Packaging and Labeling Act
- Nutrition Labeling and Education Act (NLEA)
- Import Milk Act/Filled Milk Act
- Federal Caustic Poison Act
- Bioterrorism Act
- Public Health Service Act, Part F, Subpart 1, Biologic Products
- Title 21 CFR Subpart E - Imports and Exports (1.83), etc.
- Title 19 CFR Customs Duties (authority to sample delegated by Custom Regulations, etc.)
6.1.2 - IMPORT INVESTIGATIONS
Import operations, normally focus on entry review, field examinations, and sample collections. However, investigations are an essential tool in uncovering and developing evidence documenting violations such as entry misdeclaration, product substitutions, and “port shopping.” Invaluable sources of information include: Import Alerts, assignments from headquarters or other districts, interagency cooperation and local intelligence.
When documenting these situations, your supervisor may request a memo of investigation or an EIR to be sent to the compliance branch. Follow your district procedures, IOM Chapter 5 for preparation of the EIR and IOM Subchapter 8.10 for preparation of memorandums.
When examining, sampling, or following up on refused imported products you may use an affidavit to document the facts surrounding the situation. Refer to IOM 4.4.8 and Exhibit 6-5 for guidance on preparation of an affidavit.
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