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21 CFR 211.113(b) citations

Validation lacking for sterile drug products

FDA investigators cited 21 CFR 211.113(b) 1,066 times at 608 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
202660
202579
202482
202357
202250
202130
202027
201984
201853
201764

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 StatesProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
Aug 12, 2026Steril-Gene Life Sciences Private LtdIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Aug 12, 2026Steril-Gene Life Sciences Private LtdIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Jun 30, 2026Meridian Medical Technologies, LLC A Subsidiary Of Kindeva Drug Delivery, L.P.United StatesProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
Jun 30, 2026OneSource Specialty Pharma LimitedIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Jun 26, 2026Hetero Labs Ltd. Unit VIIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Jun 23, 2026Scinopharm Taiwan, Ltd.TaiwanProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Jun 23, 2026Scinopharm Taiwan, Ltd.TaiwanProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Jun 5, 2026Pillar5 Pharma Inc.CanadaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
May 21, 2026Oakwood Laboratories LLCUnited StatesProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
May 21, 2026Oakwood Laboratories LLCUnited StatesProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
May 19, 2026Novartis Pharma Stein AGSwitzerlandProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
May 19, 2026Samchundang Pharm Co., Ltd.Korea (the Republic of)Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
May 19, 2026Samchundang Pharm Co., Ltd.Korea (the Republic of)Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
May 15, 2026Emcure Pharmaceuticals LimitedIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
May 15, 2026Emcure Pharmaceuticals LimitedIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
May 15, 2026Unither Manufacturing LLC.United StatesProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
May 5, 2026Zydus Lifesciences LimitedIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
May 5, 2026Zydus Lifesciences LimitedIndiaProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
Apr 29, 2026Samson Pharmaceuticals, IncUnited StatesProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Apr 24, 2026Hanlim Pharm Co. Ltd.Korea (the Republic of)Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Apr 24, 2026Hanlim Pharm Co. Ltd.Korea (the Republic of)Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Apr 21, 2026Altaire Pharmaceuticals, Inc.United StatesProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Apr 14, 2026Rohto-Mentholatum (Vietnam) Co., Ltd.VietnamProcedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Apr 14, 2026Rohto-Mentholatum (Vietnam) Co., Ltd.VietnamProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

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