C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 600—BIOLOGICAL PRODUCTS: GENERAL › Subpart C—Establishment Inspection

21 C.F.R. § 600.20

Inspectors

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Inspections shall be made by an officer of the Food and Drug Administration having special knowledge of the methods used in the manufacture and control of products and designated for such purposes by the Commissioner of Food and Drugs, or by any officer, agent, or employee of the Department of Health and Human Services specifically designated for such purpose by the Secretary.

[38 FR 32048, Nov. 20, 1973]
Notes of Decisions
Cited in 3 cases, 1986–1988 · leading case: Graham Ex Rel. Graham v. Wyeth Labs., 666 F. Supp. 1483 (D. Kan. 1987).
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Graham Ex Rel. Graham v. Wyeth Labs., 666 F. Supp. 1483 (D. Kan. 1987). “21 C.F.R. §§ 600.20 , 211, subpart B. Specific tests are required for each batch of vaccine, the results of which must be submitted to the FDA for review.”
Hurley v. Lederle Labs., Div. of Am. Cyanamid Co., 651 F. Supp. 993 (E.D. Tex. 1986). “21 C.F.R. § 600.20 . 18 . 21 C.F.R. § 610 , subparts A and B.”
Abbot v. Am. Cyanamid Co., 844 F.2d 1108 (4th Cir. 1988). “21 C.F.R. §§ 600.20 , 601.1, 601.2, 601.25, 610.”
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