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Inspection References
Investigations Operations Manual 2008
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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:

  1. Federal Food, Drug, and Cosmetic Act
  2. Fair Packaging and Labeling Act
  3. Nutrition Labeling and Education Act (NLEA)
  4. Import Milk Act/Filled Milk Act
  5. Federal Caustic Poison Act
  6. Bioterrorism Act
  7. Public Health Service Act, Part F, Subpart 1, Biologic Products
  8. Title 21 CFR Subpart E - Imports and Exports (1.83), etc.
  9. Title 19 CFR Customs Duties (authority to sample delegated by Custom Regulations, etc.)

6.1.2 - IMPORT INVESTIGATIONS

Begin Changed TextImport 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.End Changed Text

 

Begin Changed TextWhen 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, End Changed Text Begin Changed TextIOM Chapter 5End Changed TextBegin Changed Text for preparation of the EIR and End Changed Text Begin Changed TextIOM Subchapter 8.10End Changed TextBegin Changed Text for preparation of memorandums.  End Changed Text

 

Begin Changed TextWhen examining, sampling, or following up on refused imported products you may use an affidavit to document the facts surrounding the situation.  Refer to End Changed Text Begin Changed TextIOM 4.4.8End Changed TextBegin Changed Text and Exhibit 6-5 for guidance on preparation of an affidavit.End Changed Text

 

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