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21 CFR 211.182 citations

Written records kept in individual logs

FDA investigators cited 21 CFR 211.182 324 times at 291 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 13, 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
20264
202513
202413
202310
202213
20215
202010
201918
201818
201724

Recent citations

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

Inspection endedFacilityCountryObservation
Jul 13, 2026Conopco Inc. D/B/A UnileverUnited StatesWritten records of major equipment maintenance and use are not included in individual equipment logs.
Jun 4, 2026Nexus Pharmaceuticals, LLCUnited StatesWritten records of major equipment maintenance are not included in individual equipment logs.
Apr 24, 2026Aspire Pharmaceuticals, Inc.United StatesThe persons performing and double-checking the cleaning and maintenance are not dating the equipment cleaning and use log.
Mar 20, 2026Eosera, Inc.United StatesIndividual equipment logs do not show time, date, product and lot number of each batch processed.
Sep 26, 2025EUROSIREL S.P.AItalyWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Sep 25, 2025Eurofins BioPharma Product Testing ENCO, LLC.United StatesWritten records of major equipment use are not included in individual equipment logs.
Sep 12, 2025Nippon Shikizai, Inc.JapanIndividual equipment logs do not show time, product and lot number of each batch processed.
Aug 12, 2025Fareva Morton Grove, Inc.United StatesWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Jul 28, 2025DOH Central PharmacyUnited StatesWritten records of major equipment cleaning and use are not included in individual equipment logs.
Jun 26, 2025Dhaliwal Labs South LLCUnited StatesWritten records of major equipment cleaning and use are not included in individual equipment logs.
Mar 28, 2025Murty Pharmaceuticals, IncUnited StatesIndividual equipment logs do not show time, product and lot number of each batch processed.
Mar 25, 2025Creative Essences IncUnited StatesWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Feb 12, 2025Aidance Scientific IncUnited StatesWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Feb 12, 2025AVASOL LLCUnited StatesWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Nov 25, 2024Exel Inc.United StatesWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Nov 13, 2024Avantor Performance Materials LLCUnited StatesThe persons double-checking the cleaning and maintenance are not signing or initialing the equipment cleaning and use log.
Oct 18, 2024INDUCTION THERAPIES LLCUnited StatesWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Sep 30, 2024Airgas USA, LLCUnited StatesWritten records of major equipment use are not included in individual equipment logs.
Sep 27, 2024Erkul Kozmetik Sanayi Ve Ticaret A.S.TurkeyThe entries in the equipment cleaning and use logs are not in chronological order.
Sep 27, 2024Future Foam, Inc.United StatesThe persons performing and double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.
Sep 20, 2024Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim SirketiTurkeyWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Jul 29, 2024Denison Pharmaceuticals, LLCUnited StatesWritten records of major equipment cleaning are not included in individual equipment logs.
May 31, 2024Diora Kimya Sanayi Ve Ticaret Limited SirketiTurkeyWritten records of major equipment cleaning and use are not included in individual equipment logs.
May 22, 2024Thorn BioScience LLCUnited StatesWritten records of major equipment cleaning are not included in individual equipment logs.
May 8, 2024Neilmed Pharmaceuticals IncUnited StatesWritten records of major equipment cleaning, maintenance and use are not included in individual equipment logs.

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