C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart J—Records and Reports

21 C.F.R. § 211.192

Production record review

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All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.

Notes of Decisions
Cited in 9 cases (3 in the last 5 years), 1988–2025 · leading case: Crocker v. Kv Pharm. Co., 782 F. Supp. 2d 760 (E.D. Mo. 2010).
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Crocker v. Kv Pharm. Co., 782 F. Supp. 2d 760 (E.D. Mo. 2010). · cites it 2× “Failure to make written records of investigations into unexplained discrepancies and investigations of a batch or any of its components to meet specifications, as required by 21 C.F.R. § 211.192 ; d. Failure to review and approve drug product production and control records by…”
Mulligan v. Impax Labs., Inc., 36 F. Supp. 3d 942 (N.D. Cal. 2014). “Both the Form 483 and subsequent EIR noted that these deficiencies were a violation of 21 C.F.R. § 211.192 which requires unexplained discrepancies to be thoroughly investigated.”
John D. Copanos & Sons, Inc. & Kanasco, Ltd. v. Food & Drug Admin. & Frank E. Young, M.D., ph.d., Comm'r of Food & Drugs, 854 F.2d 510 (D.C. Cir. 1988). “at 29285; 21 C.F.R. § 211.192 (requiring “any unexplained discrepancy” in production and control records to be “thoroughly investigated,” and a “written report of the investigation” to be prepared).”
Pub. Pension Fund Grp. v. Kv Pharm. Co., 705 F. Supp. 2d 1088 (E.D. Mo. 2010). · cites it 2× “Failure to make written records of investigations into unexplained discrepancies and the failure to make written records of investigations of a batch or any of its components to meet specifications, as required by 21 C.F.R. § 211.192 ; D. Failure to review and approve drug…”
United States v. Merck & Co., 44 F. Supp. 3d 581 (E.D. Pa. 2014). “§ 331 (c); 21 C.F.R. § 211.192 . (Dkt. No. 12 ¶ 115.”
United States v. Barr Labs., Inc., 812 F. Supp. 458 (D.N.J. 1993). “21 C.F.R. § 211.192 ; see (924:19 (Ger-raughty) (violation of CGMP to discard out-of-specification results and pass batch on retesting alone)).”
Pfizer Inc. & Tris Pharma, Inc. v. the State of Texas & Tarik Ahmed (Tex. App. 2025). · cites it 3× “Through these CGMP regulations, the FDA requires pharmaceutical manufacturers to institute standard processes for evaluating the quality of their products and to thoroughly investigate complaints about their products as well as unexplained discrepancies in product quality.”
Pfizer Inc. & Tris Pharma, Inc. v. the State of Texas & Tarik Ahmed (Tex. App. 2025). · cites it 3× “16 We cite 21 CFR 211.192 in paragraph 21, 17 which talks about production control records.”
Daugherty v. Padagis Israel Pharm. Ltd. (N.D. Cal. 2025). “9 21 C.F.R. § 211.192 (emphasis added). What constitutes a “thorough” investigation, such that a 10 manufacturer can be said to have complied with § 211.”
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