CPG Sec. 130.100 Inspectional Authority; Refusal to Permit Inspection.
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.
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)
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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