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 I—Production and Process Control System: Requirements for the Batch Production Record

21 C.F.R. § 111.255

What is the requirement to establish a batch production record?

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(a) You must prepare a batch production record every time you manufacture a batch of a dietary supplement;

(b) Your batch production record must include complete information relating to the production and control of each batch;

(c) Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and

(d) You must make and keep batch production records in accordance with subpart P of this part.

Notes of Decisions
Cited in 1 case, 2015–2015 · leading case: United States v. Cole, 84 F. Supp. 3d 1159 (D. Or. 2015).
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United States v. Cole, 84 F. Supp. 3d 1159 (D. Or. 2015). “210; and (4) each time a batch is produced, document the execution of (and any deviations from) the MMR in a Batch Production Record (“BPR”), 21 C.F.R. §§ 111.255 ,111.260. The Government alleges and has presented evidence that Maxam’s manufacturing processes violated each of…”
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