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21 CFR 211.113(a) citations

Procedures for non-sterile drug products

FDA investigators cited 21 CFR 211.113(a) 328 times at 295 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jun 26, 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
202614
202519
202421
202316
202219
202110
20206
201921
201825
201726

Recent citations

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

Inspection endedFacilityCountryObservation
Jun 26, 2026S.S.S. Company (International)United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
May 15, 2026Owen Biosciences Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
May 13, 2026Advagen Holdings, Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
May 1, 2026SnugZ USA, Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Feb 27, 2026Gasco Industrial Corp.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Feb 27, 2026Tan-Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret A.S.TurkeyProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Feb 26, 2026CoreRX Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Feb 12, 2026Tropical Seas, Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Feb 5, 2026Nice-Pak Products, LLCUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Jan 30, 2026Hibrow Healthcare Private LimitedIndiaProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Dec 22, 2025Blaine Labs IncUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and written.
Dec 12, 2025Greer Laboratories, Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Dec 9, 2025Bavarian Nordic A/SDenmarkProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Dec 5, 2025Ecolab LLCUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Sep 29, 2025Lexia LLCUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Sep 26, 2025Alcami Carolinas CorporationUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Sep 19, 2025Actavis Laboratories UT, Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not written.
Aug 22, 2025Lonza Tampa LLCUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Aug 15, 2025United Laboratories Manufacturing, LLCUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Aug 12, 2025Fareva Morton Grove, Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
Aug 7, 2025Sumitomo Pharma Co., Ltd.JapanProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Apr 29, 2025OHM Pharma, Inc.United StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Apr 24, 2025Teva Canada LimitedCanadaProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
Apr 9, 2025Kavis Pharma LLCUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and written.
Apr 4, 2025USAntibiotics LLCUnited StatesProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.

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