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21 CFR 211.22(d) citations

Procedures not in writing, fully followed

FDA investigators cited 21 CFR 211.22(d) 2,413 times at 1,844 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 23, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
2026121
2025221
2024171
2023115
2022123
202168
202079
2019164
2018168
2017159

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
Sep 23, 2026Baxter Healthcare CorporationUnited StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Aug 20, 2026PD-Rx Pharmaceuticals, Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Aug 14, 2026AVEVA Drug Delivery Systems, Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Aug 12, 2026A-S Medication Solutions LLCUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Jul 30, 2026Sterigenics U.S., LLCUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing.
Jul 22, 2026Neilmed Pharmaceuticals IncUnited StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jul 17, 2026I. Shay Cosmetics IncUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Jul 14, 2026Aspen SA Sterile Operations (Pty) Ltd.South AfricaThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jul 13, 2026Conopco Inc. D/B/A UnileverUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Jul 10, 2026Wasatch Product Development, LLCUnited StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jun 30, 2026Carlsbad Technology, IncUnited StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jun 26, 2026Advanced Cosmetic Research Laboratories, Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jun 26, 2026Boiron Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jun 19, 2026Nowcos Co., Ltd.Korea (the Republic of)The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Jun 18, 2026American Regent Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jun 16, 2026Advanced Testing Laboratory IncUnited StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
Jun 12, 2026Epic Pharma, LLCUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Jun 12, 2026Inspec Solutions LLCUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Jun 12, 2026Product Society LLCUnited StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
May 29, 2026Cosmoceutical Research Center, Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
May 27, 2026API Solutions Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not fully followed.
May 27, 2026Unit Dose Solutions, Inc.United StatesThe responsibilities and procedures applicable to the quality control unit are not in writing.
May 22, 2026Apnar Pharma LLPUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
May 22, 2026I 3 PHARMACEUTICALS, LLCUnited StatesThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
May 19, 2026Novartis Pharma Stein AGSwitzerlandThe responsibilities and procedures applicable to the quality control unit are not fully followed.

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Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.