21 CFR 211.22
Responsibilities of quality control unit
21 CFR 211.22 is the regulation titled “Responsibilities of quality control unit” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 292 FDA warning letters have cited it.
- Letters citing it
- 292 since 2021
- Jan 1 to Oct 30, 2026
- 66 against 52 on the same dates in 2025
- Most often cited with
- 21 CFR 211.84, in 177 letters
- Closed out
- 4% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (287 of 292). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.22 most often, as written in the letters.
- 45 lettersYour firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials,…
- 13 lettersYour firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d))
- 10 lettersYour firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d))
The regulation
Read the text of 21 CFR 211.22 (eCFR, as of Sep 1, 2026)
(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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.22.
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures177 letters cite both
- 21 CFR 211.100Written procedures; deviations147 letters cite both
- 21 CFR 211.165Testing and release for distribution108 letters cite both
- 21 CFR 211.166Stability testing98 letters cite both
- 21 CFR 211.192Production record review84 letters cite both
- 21 CFR 211.160General requirements72 letters cite both
- 21 CFR 201.128Meaning of “intended uses”60 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance60 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.22 that FDA posted most recently.
- DrugsView Conroe Welding Supply, Inc.Oxygen, USP for administration by inhalationIssuedOct 29, 2026PostedNov 3, 2026
- DrugsView Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.OTC drug products, including (b)(4)IssuedOct 27, 2026PostedNov 3, 2026
- DrugsView Pritam International Private LimitedBrush Buddies Cookies 'n Cream Ice Cream Flavored ToothpasteIssuedOct 27, 2026PostedNov 3, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.