C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Subpart A—General Provisions

21 C.F.R. § 110.5

Current good manufacturing practice

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(a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264).

(b) Food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations.

Notes of Decisions
Cited in 3 cases, 2012–2016 · leading case: United States v. Am. Mercantile Corp., 889 F. Supp. 2d 1058 (W.D. Tenn. 2012).
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United States v. Am. Mercantile Corp., 889 F. Supp. 2d 1058 (W.D. Tenn. 2012). “21 C.F.R. § 110.5 . . United States v. 1,500 Cases More or Less, Tomato Paste, 236 F.”
United States v. N.Y. Fish, Inc., 10 F. Supp. 3d 355 (E.D.N.Y 2014). “” 21 C.F.R. § 110.5 (a). . In particular, Kutsyk avers that he repaired a hole and broken tile above a fish processing table, as well as other damaged tiles; submitted revised HACCP plans for both hot- and cold-smoked products; purchased color-coordinated cleaning supplies;…”
United States v. Scotty's Inc., 173 F. Supp. 3d 549 (E.D. Mich. 2016). “21 C.F.R. § 110.5 (a). These regulations require the “grounds about a food plant under the control of the operator [to be] kept in a condition that will protect against the contamination of food.”
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