FDA GUIDANCE to Investigators on SAMPLE/INSPECTION REFUSAL

4.2.3 - REFUSAL TO PERMIT SAMPLING

Challenges to FDA authority while collecting samples may be encountered by a dealer who, for various reasons including, personal and professional, opposes the activities of the Agency, or of governmental units in general.

Refusals to permit sample collection commonly emerge unless you can identify a section of the law which specifi- cally authorizes it. The suggested approach for dealing with these individuals is to use patient, tactful persuasion, pointing out that the sample is a part of the investigations authorized in Section 702(b) of the FD&C Act [21 U.S.C. 372(b)]. If you have not already done so, issue an FDA 482 - Notice of Inspection (except in the case of foreign inspections- see IOM 5.1.3) as soon as it becomes apparent the dealer will continue to object.

Point out and discuss the authorities provided by FD&C Act sections 702(a), 702(b), 704(a), 704(c), 704(d) [21 U.S.C. 372(a),(b), 374(a), (c), (d)] and the precedent case mentioned in IOM 2.2.1. If refusal persists, point out the criminal prohibitions of Section 301(f) of the FD&C Act [21 U.S.C. 331(f)].

If samples are still refused, leave the premises and con- tact your supervisor immediately. Refer to IOM section 5.2.5 and Compliance Policy Guide manual section 130.100 for further discussions on resolving the impasse.

4.2.3.1 - Limiting or Preventing Collection of Samples of a Drug

Preventing an authorized representative of the FDA from collecting drug samples may be considered as limiting the inspection. If you have appropriately issued a FDA 482 – Notice of Inspection and the dealer impedes your ability to collect samples, point out and discuss the authority provided by Section 501(j) of the FD&C Act [21 U.S.C. 351(j)] under Section 707 of the Food and Drug Administration Safety and Innovation Act (FDASIA), that potentially deems all drugs manufactured at the facility adulterated in the case of limiting an inspection. In situations where you have begun an inspection but no FDA 482 is issued (e.g., foreign inspections), document this fact and the limiting activities in your notes based on the authority described above. If refusal persists, point out that adulteration under section 501(j) of the FD&C Act [21 U.S.C. 351(j)] could lead to further prohibited acts under 301(a), (b), and (c) [21 U.S.C. 331(a), (b), (c)]).

The authority for duly appointed officers or employees of the Food and Drug Administration to enter and inspect establishments under the jurisdiction of the Federal Food, Drug, and Cosmetic Act is in Section 704 of the Act (21 U.S.C. 374).

Questions concerning the right to inspect such establishments have often been raised and litigated. The courts have upheld the legality of an FDA inspection if it is conducted at a reasonable time, within reasonable limits and in a reasonable manner*. Consent is not the basis upon which a Food and Drug inspection is conducted, and permission or authorization to inspect is not required from the firm to be inspected.

The Federal Food, Drug, and Cosmetic Act provides criminal penalties for refusal to permit a lawful inspection.

POLICY:

The legality of an FDA inspection, conducted at a reasonable time, and within reasonable limits, and in a reasonable manner, depends not on consent but on the validity of statutory authority. An inspection warrant is not a prerequisite to lawful inspection pursuant to such authority. Refusal to permit inspection, upon presentation of official notice by appropriately identified Food and Drug Administration officers or employees pursuant to 21 U.S.C. 374, exposes any person responsible for such refusal to criminal penalties under 21 U.S.C. 331(f) and 333.

*United States v. Biswell, 92 S. Ct. 1593 (1972)

United States v. Del Campo Baking Mfg. Company, 345 F. Supp. 1371 (D., Del., 1972)

United States v. Business Builders, Inc., 353 F. Supp. 1333 (N.D. Okla., 1973)

Issued: 10/1/80