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 B—Organization and Personnel

21 C.F.R. § 211.22

Responsibilities of quality control unit

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(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.

(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

Notes of Decisions
Cited in 6 cases (1 in the last 5 years), 1984–2025 · leading case: In Re: Ocular Therapeutix Inc v., 955 F.3d 194 (1st Cir. 2020).
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In Re: Ocular Therapeutix Inc v., 955 F.3d 194 (1st Cir. 2020). “" See 21 C.F.R. § 211.22 (a). Further, "[p]articulate matter has been noted in 10/23 lots .”
Crocker v. Kv Pharm. Co., 782 F. Supp. 2d 760 (E.D. Mo. 2010). “Failure to follow the responsibilities and procedures applicable to the quality control unit, as required by 21 C.F.R. § 211.22 (d); b. Failure to establish control procedures to validate the performance of those manufacturing processes that may be responsible for causing…”
Nat'l Ass'n of Pharm. Mfrs. v. Dep't of Health & Human Servs., 586 F. Supp. 740 (S.D.N.Y. 1984). “Quality Control Unit Many of the regulations challenged by plaintiffs relate to the duties to be performed by the quality control unit which each manufacturer must establish pursuant to 21 C.F.R. § 211.22 . Plaintiffs challenge virtually every regulation governing the…”
Pub. Pension Fund Grp. v. Kv Pharm. Co., 705 F. Supp. 2d 1088 (E.D. Mo. 2010). “Failure to follow the responsibilities and procedures applicable to the quality control unit, as required by 21 C.F.R. § 211.22 (d); B. Failure to establish control procedures to validate the performance of those manufacturing processes that may be responsible for causing…”
Akorn, Inc. v. Fresenius Kabi AG (Del. Ch. 2018). “38 JX 112 at 9–10 (citing 21 C.F.R. §§ 211.22 (a), 211.125(c), 211.”
Pfizer Inc. & Tris Pharma, Inc. v. the State of Texas & Tarik Ahmed (Tex. App. 2025). “16 21 CFR § 211.22 (a). 17 See id. PLAINTIFFS’ SECOND AMENDED PETITION PAGE 7 approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.”
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