§ 211.22 Responsibilities of quality control unit.

Law · 21 CFR 211.22 · eCFR as of 25 Sep 2026 · checked 30 Sep 2026 · Official source: ecfr.gov

Cited in 3 FDA warning lettersHow BatchGlow handles this

(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.

Cited in FDA warning letters

3 of the 6 FDA warning letters in this collection (2023–2026, cosmetic and OTC manufacturers) cite this section as a violation.

How BatchGlow handles this

A lot is accepted or rejected only by a signed QC decision, made by a QC user who entered none of its results; for a drug, a result out of specification is investigated before the lot is rejected.

What it asks for, in plain words

21 CFR 211.22
A quality control unit has the responsibility and authority to approve or reject all components, containers, closures, in-process materials, packaging, labeling and drug products, and to review production records to make sure that no errors have occurred or, if they have, that they were fully investigated. It approves or rejects every procedure and specification that affects the product's identity, strength, quality and purity, has adequate laboratory facilities, and works by written procedures that are followed.

These summaries are BatchGlow's reading of the text on this page, checked against it on 5 Oct 2026. The text governs.