https://cdmoledger.pages.dev/recent/This is a record of what regulators published, not a rating.https://cdmoledger.pages.dev/sites/curia-rensselaer-new-york/aab3c933f873Fri, 18 Sep 2026 00:00:00 +0000Compliance action recorded by FDA for FEI 1310298; case/injunction ID 728790. Letter subject: CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).https://cdmoledger.pages.dev/sites/curia-aurangabad-india/a4d1424a2e20Tue, 21 Jul 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.https://cdmoledger.pages.dev/sites/solvias-canton-massachusetts/ad12bc896096Thu, 16 Jul 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.68(b): input/output verificationhttps://cdmoledger.pages.dev/sites/solvias-canton-massachusetts/d505cf1a7136Thu, 16 Jul 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/thermo-fisher-scientific-swindon-united-kingdom/2dcc4be88dfcTue, 07 Jul 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/thermo-fisher-scientific-greenville-north-carolina/8661af876f2dTue, 30 Jun 2026 00:00:00 +0000No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.https://cdmoledger.pages.dev/sites/frontage-laboratories-exton-pennsylvania/0abe433bf2adThu, 18 Jun 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring.https://cdmoledger.pages.dev/sites/thermo-fisher-scientific-florence-south-carolina/fcc12681e8c3Fri, 12 Jun 2026 00:00:00 +0000No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/pace-life-sciences-oakdale-minnesota/38d6bea89f17Fri, 29 May 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.194(a): Complete test data included in records | 21 CFR 211.68(b): input/output verificationhttps://cdmoledger.pages.dev/sites/agc-biologics-bothell-washington/f852b0845adbFri, 29 May 2026 00:00:00 +0000No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/pace-life-sciences-oakdale-minnesota/145ff1ce988dFri, 29 May 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/catalent-morrisville-north-carolina/89ff367d0969Fri, 22 May 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.67(b): Written procedures not established/followedhttps://cdmoledger.pages.dev/sites/catalent-morrisville-north-carolina/0a394c0cc93eFri, 22 May 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/bachem-vista-california/df69cedb31dfWed, 20 May 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/lonza-bend-oregon/4d9350574fa9Tue, 19 May 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.192: Investigations of discrepancies, failureshttps://cdmoledger.pages.dev/sites/lonza-bend-oregon/2651305077b7Tue, 19 May 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.192: Investigations of discrepancies, failureshttps://cdmoledger.pages.dev/sites/lonza-bend-oregon/cab8b7e92578Tue, 19 May 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/lonza-bend-oregon/1c251a0ba5a5Tue, 19 May 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/unither-pharmaceuticals-rochester-new-york/9c3dae224240Fri, 15 May 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.113(b): Procedures for sterile drug products | 21 CFR 211.142(b): Storage under appropriate conditions | 21 CFR 211.160(b): Scientifically sound laboratory controls | 21 CFR 211.165(b): Microbiological testing | 21 CFR 211.165(d): Acceptance criteria for sampling & testing | 21 CFR 211.166(a): Lack of written stability program | 21 CFR 211.22(d): Procedures not in writing, fully followed | 21 CFR 211.67(b): Written procedures not established/follohttps://cdmoledger.pages.dev/sites/unither-pharmaceuticals-rochester-new-york/683de130cb89Fri, 15 May 2026 00:00:00 +0000Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/bachem-torrance-california/a0356c9e9241Mon, 04 May 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/ppd-middleton-wisconsin/811dcc1201a0Fri, 01 May 2026 00:00:00 +0000No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products; Human Cellular, Tissue, and Gene Therapies.https://cdmoledger.pages.dev/sites/alcami-charleston-south-carolina/f7f9b337c4d9Wed, 22 Apr 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.100(a): Absence of Written Procedures | 21 CFR 211.160(a): Lab controls established, including changes | 21 CFR 211.192: Investigations of discrepancies, failures | 21 CFR 211.194(a)(8): Second person sign off | 21 CFR 211.194(a): Complete test data included in records | 21 CFR 211.22(d): Procedures not in writing, fully followed | 21 CFR 211.25(a): Training , Education , Experience overallhttps://cdmoledger.pages.dev/sites/alcami-charleston-south-carolina/bdfef8c9dbe7Wed, 22 Apr 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Veterinary. Project area(s): Pre-Approval Eval. of Animal Drugs and Food Additives.https://cdmoledger.pages.dev/sites/sharp-services-allentown-pennsylvania/4b72cbbef683Wed, 22 Apr 2026 00:00:00 +0000No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.https://cdmoledger.pages.dev/sites/frontage-laboratories-exton-pennsylvania/da4d2420eb97Tue, 14 Apr 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.160(b): Scientifically sound laboratory controls | 21 CFR 211.192: Written record of investigation incomplete | 21 CFR 211.194(a)(4): Data secured in course of each test | 21 CFR 211.68(b): Backup file not maintainedhttps://cdmoledger.pages.dev/sites/frontage-laboratories-exton-pennsylvania/767fbb77037dTue, 14 Apr 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/kbi-biopharma-durham-north-carolina/0f71ec5660a4Wed, 01 Apr 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/simtra-biopharma-solutions-halle-westf-germany/e29e47a96613Tue, 03 Mar 2026 00:00:00 +0000Compliance action recorded by FDA for FEI 3002806419; case/injunction ID 720436. Letter subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).https://cdmoledger.pages.dev/sites/thermo-fisher-scientific-monza-italy/0509b6003eadTue, 10 Feb 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenancehttps://cdmoledger.pages.dev/sites/thermo-fisher-scientific-monza-italy/164fb4f3a912Tue, 10 Feb 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products; Vaccines and Allergenic Products.https://cdmoledger.pages.dev/sites/alcami-charleston-south-carolina/ec42798b816aFri, 06 Feb 2026 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.110(c): In-process materials characteristics testing | 21 CFR 211.113(b): Procedures for sterile drug products | 21 CFR 211.192: Investigations of discrepancies, failures | 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System | 21 CFR 211.63: Equipment Design, Size and Location | 21 CFR 211.67(b): Written procedures fail to includehttps://cdmoledger.pages.dev/sites/lonza-portsmouth-new-hampshire/afa9ae6ede97Fri, 06 Feb 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/sharp-services-conshohocken-pennsylvania/ab47530a6372Fri, 06 Feb 2026 00:00:00 +0000No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/alcami-charleston-south-carolina/534c878a41d1Fri, 06 Feb 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/curia-rensselaer-new-york/ea16833a4f42Thu, 05 Feb 2026 00:00:00 +0000Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/thermo-fisher-scientific-ferentino-italy/cfb04f5ba16eFri, 30 Jan 2026 00:00:00 +0000No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.https://cdmoledger.pages.dev/sites/catalent-saint-petersburg-florida/3897dbb8d0c3Fri, 30 Jan 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/olon-casaletto-lodigiano-italy/76ea8a9fa425Fri, 16 Jan 2026 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/catalent-philadelphia-pennsylvania/e179d3837125Wed, 17 Dec 2025 00:00:00 +0000No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.https://cdmoledger.pages.dev/sites/hovione-taipa-macao/9126be4e7b37Fri, 12 Dec 2025 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/piramal-pharma-solutions-lexington-kentucky/942a82d39371Wed, 10 Dec 2025 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.100(a): Absence of Written Procedures | 21 CFR 211.113(b): Procedures for sterile drug products | 21 CFR 211.192: Investigations of discrepancies, failures | 21 CFR 211.68(b): Computer control of master formula recordshttps://cdmoledger.pages.dev/sites/piramal-pharma-solutions-lexington-kentucky/18988a9d202dWed, 10 Dec 2025 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.https://cdmoledger.pages.dev/sites/curia-springfield-missouri/245b91a7ea4aTue, 02 Dec 2025 00:00:00 +0000No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/curia-bon-encontre-france/e97640f785e6Thu, 27 Nov 2025 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/sharp-services-allentown-pennsylvania/ae4005f47b34Fri, 21 Nov 2025 00:00:00 +0000No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/carbogen-amcis-bubendorf-switzerland/3482cccdebfaFri, 14 Nov 2025 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/kindeva-drug-delivery-northridge-california/a3d6e352985dThu, 13 Nov 2025 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.110(a): Control procedures to monitor and validate performance | 21 CFR 211.192: No written record of investigationhttps://cdmoledger.pages.dev/sites/kindeva-drug-delivery-northridge-california/a3a9c6775a3cThu, 13 Nov 2025 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/grand-river-aseptic-manufacturing-grand-rapids-michigan/eb6ee365ce59Tue, 04 Nov 2025 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.113(b): Validation lacking for sterile drug products | 21 CFR 211.22(d): Procedures not in writing, fully followedhttps://cdmoledger.pages.dev/sites/grand-river-aseptic-manufacturing-grand-rapids-michigan/fa99e5fc112dTue, 04 Nov 2025 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.https://cdmoledger.pages.dev/sites/catalent-greenville-north-carolina/0497551a26c6Fri, 24 Oct 2025 00:00:00 +0000Citation summaries published by FDA: 21 CFR 211.165(b): Microbiological testing | 21 CFR 211.166(a): Written program not followed | 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenancehttps://cdmoledger.pages.dev/sites/catalent-greenville-north-carolina/ddb97fe7ecb8Fri, 24 Oct 2025 00:00:00 +0000Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.