C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS › Subpart C—Physical Plant and Grounds

21 C.F.R. § 111.23

Under this subpart C, what records must you make and keep?

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(a) You must make and keep records required under this subpart C in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for cleaning the physical plant and for pest control.

(c) You must make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of § 111.15(e)(2).

Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2021–2021 · leading case: United States v. 286,161 bottles, 209 dietary supplement cookie packs, & 45,521 packs, boxes, or granules, more or less, of an article of food, specifically various herbal supplement capsules, tablets, cookies, & teas (N.D. Ill. 2021).
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United States v. 286,161 bottles, 209 dietary supplement cookie packs, & 45,521 packs, boxes, or granules, more or less, of an article of food, specifically various herbal supplement capsules, tablets, cookies, & teas (N.D. Ill. 2021). “14; (2) failure to have written procedures for pest control in violation of 21 C.F.R. § 111.23 (b); (3) failure to have at least one person formally designated to supervise overall sanitation procedures in violation of 21 C.”
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