21 CFR 211.22: Responsibilities of quality control unit
Requires drug manufacturers to maintain an independent quality control unit with authority to approve or reject materials, products, contractor-made drugs, and specifications, review production records for errors, use adequate labs, and follow written procedures.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart B, Organization and Personnel
40%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.22, from the 483s we hold.
The responsibilities and procedures applicable to the quality control unit are not fully followed.Most used
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.211.22(d)
Cited over time
483s citing 211.22, by yearMost citations in 2024. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2024.
Recent 483s citing 211.22
- Right Value Drug Stores LLC · Irving, TexasThe responsibilities and procedures applicable to the quality control unit are not… Sep 8, 2026
- Imprimis NJOF, LLC · Ledgewoo d, New JerseyThe quality control unit lacks the responsibility and authority to approve and… Aug 18, 2026
- IntegraDose Compound ing Services LLC · Shoreview, MinnesotaThe responsibilities and procedures applicable to the quality control unit are not… Aug 12, 2026
- Apollo Care, LLC · Columbia, MissouriThere is a failure ofthe quality control unit to secure their responsibility and… Jul 28, 2026
- Cascade Specialty Pharmacy, LLC · Poulsbo, WashingtonThe responsibilities and procedures applicable to the quality control unit are not… Jul 17, 2026
The regulation text
§ 211.22 Responsibilities of quality control unit.
(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.
Questions
What does 21 CFR 211.22 require?
Requires drug manufacturers to maintain an independent quality control unit with authority to approve or reject materials, products, contractor-made drugs, and specifications, review production records for errors, use adequate labs, and follow written procedures.
How often is 211.22 cited in Form 483s?
It appears in about 40% of the drug-manufacturing 483s we hold from 2023 onward, which makes it one of the five most-cited sections in those 483s.
How do FDA investigators word a 211.22 observation?
The most common opening is: “The responsibilities and procedures applicable to the quality control unit are not fully followed.”
Which sections are cited alongside 211.22?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.160 (General requirements), 211.67 (Equipment cleaning and maintenance), 211.100 (Written procedures; deviations).