> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # FDA Releases 79 More Form 483 Inspection Records - URL: https://www.fdaweb.com/fda-releases-79-more-form-483-inspection-records/ - Published: 2026-10-27T23:00:00.000Z - Updated: 2026-10-27T23:16:18.000Z - Author: David McFarland - Tags: enforcement FDA published another 79 Form 483 inspection records on 10/26 through the Office of Inspections and Investigations FOIA Electronic Reading Room, continuing a series of substantial disclosures of previously unavailable inspection documents. Their availability is part of the agency’s expanded transparency initiative ([see earlier story](https://www.fdaweb.com/fda-unveils-transparency-roadmap-plans-more-disclosures/)), but a significant limitation in the agency's online FOIA Electronic Reading Room makes it difficult for users to identify newly posted documents: the database does not allow records to be sorted by publication date. Companies represented in this batch include GSK, Serum Institute of India, Sanofi Pasteur, Seqirus, Eugia Steriles, Replimune, AGC Biologics, ADMA Biologics and Bio-Rad Laboratories. The records are listed below by FDA publication date, with links to individual Form 483 documents where available. Previous Form 483 posts can be [viewed here](FDA%20published%20another%2079%20Form%20483%20inspection%20records%20on%2010/26%20through%20its%20Office%20of%20Inspections%20and%20Investigations%20FOIA%20Electronic%20Reading%20Room,%20continuing%20a%20series%20of%20substantial%20disclosures%20of%20previously%20unavailable%20inspection%20documents.). | Company | Inspection date | Establishment type | FDA Form 483 | | ----------------------------------------------------------- | --------------- | ------------------------------------------------- | --------------------------------------------------------------- | | Eugia Steriles Private Limited | Jun 19, 2026 | Sterile Drug Product Manufacturer | [PDF](https://www.fda.gov/media/195362/download?ref=fdaweb.com) | | Kristen M. Pettit, M.D. | Apr 15, 2026 | Clinical Investigator | [PDF](https://www.fda.gov/media/195365/download?ref=fdaweb.com) | | Scott & White Memorial Hospital | Apr 13, 2026 | Hospital Blood Bank | [PDF](https://www.fda.gov/media/195486/download?ref=fdaweb.com) | | Reproductive Sciences Medical Center, Inc. | Apr 08, 2026 | Human Reproductive Tissue Establishment | [PDF](https://www.fda.gov/media/195466/download?ref=fdaweb.com) | | Diana T. Widicus, M.D. | Apr 03, 2026 | Clinical Investigator | [PDF](https://www.fda.gov/media/195364/download?ref=fdaweb.com) | | Sunrise Pharmaceutical, Inc. | Mar 31, 2026 | Manufacturer | [PDF](https://www.fda.gov/media/195359/download?ref=fdaweb.com) | | Elevate Surgical | Mar 26, 2026 | HCT/P Storage & Distribution Facility | [PDF](https://www.fda.gov/media/195502/download?ref=fdaweb.com) | | Fagron Analytical Services, LLC | Mar 26, 2026 | Contract Laboratory | [PDF](https://www.fda.gov/media/195363/download?ref=fdaweb.com) | | Cantor BioConnect, Inc. | Mar 24, 2026 | Blood Component Storage and Distribution Facility | [PDF](https://www.fda.gov/media/195587/download?ref=fdaweb.com) | | KLEB Inc | Mar 17, 2026 | Human Tissue | [PDF](https://www.fda.gov/media/195462/download?ref=fdaweb.com) | | North Shore University Hospital Northwell Health | Mar 11, 2026 | Blood Bank | [PDF](https://www.fda.gov/media/195465/download?ref=fdaweb.com) | | Department of Defense - Navy | Mar 04, 2026 | Hospital Blood Bank | [PDF](https://www.fda.gov/media/195448/download?ref=fdaweb.com) | | C5 Biomedical LLC | Mar 02, 2026 | Human Tissue Establishment | [PDF](https://www.fda.gov/media/195489/download?ref=fdaweb.com) | | GSK Vaccines GmbH | Feb 27, 2026 | Licensed Biological Drug Manufacturer | [PDF](https://www.fda.gov/media/195475/download?ref=fdaweb.com) | | Serum Institute of India Private Ltd. | Jan 30, 2026 | Vaccine Manufacturer | [PDF](https://www.fda.gov/media/195470/download?ref=fdaweb.com) | | Hans Biomed Corporation | Sep 12, 2025 | Tissue Processor | [PDF](https://www.fda.gov/media/195497/download?ref=fdaweb.com) | | Qilu Pharmaceutical (Hainan) Co., Ltd. | Aug 22, 2025 | Finished Drug Product Manufacturer | [PDF](https://www.fda.gov/media/195361/download?ref=fdaweb.com) | | Hendrick Regional Laboratory Transfusion Services | Jul 02, 2025 | Transfusion Services/Blood Bank | [PDF](https://www.fda.gov/media/195503/download?ref=fdaweb.com) | | Noble Life Sciences, Inc | Jun 20, 2025 | Nonclinical Laboratory | [PDF](https://www.fda.gov/media/195464/download?ref=fdaweb.com) | | Foremount Enterprise Co., Ltd | Jun 19, 2025 | Medical Device Manufacturer | [PDF](https://www.fda.gov/media/195463/download?ref=fdaweb.com) | | EnduroMed | Jun 17, 2025 | HCT/P | [PDF](https://www.fda.gov/media/195506/download?ref=fdaweb.com) | | Innovis Health, LLC d.b.a. Essentia Health | Jun 11, 2025 | Blood Bank | [PDF](https://www.fda.gov/media/195589/download?ref=fdaweb.com) | | ENDO USA, Inc. | Jun 05, 2025 | Biological Drug Manufacturer | [PDF](https://www.fda.gov/media/195496/download?ref=fdaweb.com) | | Seqirus Inc | Jun 05, 2025 | Manufacturing | [PDF](https://www.fda.gov/media/195469/download?ref=fdaweb.com) | | Blood Connection, Inc. (The) | May 27, 2025 | Blood Bank | [PDF](https://www.fda.gov/media/195505/download?ref=fdaweb.com) | | Lattice Inc | May 22, 2025 | Software Manufacturer | [PDF](https://www.fda.gov/media/195504/download?ref=fdaweb.com) | | Sanford Clinic North | May 22, 2025 | Hospital Blood Bank | [PDF](https://www.fda.gov/media/195493/download?ref=fdaweb.com) | | Altru Health System | May 16, 2025 | Blood Bank | [PDF](https://www.fda.gov/media/195494/download?ref=fdaweb.com) | | Mission Hospitals Transfusion Service | May 15, 2025 | Hospital Transfusion service | [PDF](https://www.fda.gov/media/195452/download?ref=fdaweb.com) | | Premier Laboratory, LLC | May 14, 2025 | Contract testing facility | [PDF](https://www.fda.gov/media/195454/download?ref=fdaweb.com) | | Labcorp Early Development Laboratories, Inc. | May 07, 2025 | GLP | [PDF](https://www.fda.gov/media/195450/download?ref=fdaweb.com) | | Advanced Fertility Associates Medical Group, Inc. | May 01, 2025 | Reproductive Tissue | [PDF](https://www.fda.gov/media/195472/download?ref=fdaweb.com) | | Montefiore Medical Center | Apr 29, 2025 | Blood Bank | [PDF](https://www.fda.gov/media/195477/download?ref=fdaweb.com) | | Louisville Reproductive Center | Apr 28, 2025 | Human Tissue Establishment | [PDF](https://www.fda.gov/media/195582/download?ref=fdaweb.com) | | Replimune, lnc | Apr 24, 2025 | Manufacturer | [PDF](https://www.fda.gov/media/195457/download?ref=fdaweb.com) | | AGC Biologics, Inc. | Apr 18, 2025 | Drug Substance Manufacturer | [PDF](https://www.fda.gov/media/195509/download?ref=fdaweb.com) | | Department of Defense - Navy (U.S. Naval Hospital Naples) | Apr 15, 2025 | Hospital Blood Bank | [PDF](https://www.fda.gov/media/195474/download?ref=fdaweb.com) | | Department of Defense - Air Force, 99th Medical Group | Mar 27, 2025 | Blood Bank | [PDF](https://www.fda.gov/media/195460/download?ref=fdaweb.com) | | Lifesouth Community Blood Centers Inc. East Alabama Region | Mar 26, 2025 | Donor Center | [PDF](https://www.fda.gov/media/195508/download?ref=fdaweb.com) | | Sanofi Pasteur Limited | Mar 18, 2025 | Vaccine Manufacturer | [PDF](https://www.fda.gov/media/195467/download?ref=fdaweb.com) | | Fertility Center of Southern California | Mar 14, 2025 | Reproductive Human Tissue | [PDF](https://www.fda.gov/media/195588/download?ref=fdaweb.com) | | PURIBLOOD MEDICAL CO., LTD | Mar 14, 2025 | Manufacturer & Specification Developer | [PDF](https://www.fda.gov/media/195456/download?ref=fdaweb.com) | | Intertek USA Inc. | Mar 07, 2025 | Control Laboratory | Pending | | BioXtek LLC | Feb 26, 2025 | Human Tissue Processor | [PDF](https://www.fda.gov/media/195501/download?ref=fdaweb.com) | | ImpactOrtho Inc | Feb 06, 2025 | HCT/P Distributor | [PDF](https://www.fda.gov/media/195585/download?ref=fdaweb.com) | | Bio-Rad Laboratories, Inc. | Jan 31, 2025 | IVD Manufacturer | [PDF](https://www.fda.gov/media/195447/download?ref=fdaweb.com) | | ROSLIN CELL THERAPIES LIMITED | Jan 21, 2025 | Manufacturer | [PDF](https://www.fda.gov/media/195481/download?ref=fdaweb.com) | | Quality Bioresources, Inc | Dec 19, 2024 | Medical Device and Manufactuer | [PDF](https://www.fda.gov/media/195480/download?ref=fdaweb.com) | | ADMA Biologics, Inc | Dec 11, 2024 | Licensed Biological Drug Manufacturer | [PDF](https://www.fda.gov/media/195446/download?ref=fdaweb.com) | | Advocate Lutheran General Hospital Blood Bank | Dec 05, 2024 | Hospital Blood Bank | [PDF](https://www.fda.gov/media/195458/download?ref=fdaweb.com) | | Midwest Fertility Specialists | Nov 25, 2024 | Reproductive Establishment | [PDF](https://www.fda.gov/media/195451/download?ref=fdaweb.com) | | Reproductive Technologies, Inc. | Nov 18, 2024 | Reproductive Tissue | [PDF](https://www.fda.gov/media/195484/download?ref=fdaweb.com) | | GSK Vaccines GmbH | Nov 12, 2024 | Vaccine Bulk Product | [PDF](https://www.fda.gov/media/195449/download?ref=fdaweb.com) | | Octapharma Dessau GmbH | Nov 08, 2024 | Packaging and Labeling | [PDF](https://www.fda.gov/media/195453/download?ref=fdaweb.com) | | Lexington Medical Center | Oct 30, 2024 | Hospital Blood Bank | [PDF](https://www.fda.gov/media/195492/download?ref=fdaweb.com) | | Legacy Ortho LLC | Oct 29, 2024 | Human Tissue | [PDF](https://www.fda.gov/media/195498/download?ref=fdaweb.com) | | Rejuvenating Fertility Center PLLC/AllCare Fertility Center | Oct 25, 2024 | Human Reproductive Tissue | [PDF](https://www.fda.gov/media/195500/download?ref=fdaweb.com) | | Alon Medical Technology | Oct 16, 2024 | HCT/P Distributor | [PDF](https://www.fda.gov/media/195488/download?ref=fdaweb.com) | | Nova Laboratories Ltd | Aug 23, 2024 | Biologics - Pharmaceuticals, Medical Devices | [PDF](https://www.fda.gov/media/195478/download?ref=fdaweb.com) | | Protherics UK Limited | Aug 13, 2024 | Biological Drug Substance Manufacturer | [PDF](https://www.fda.gov/media/195483/download?ref=fdaweb.com) | | Bio-Rad Medical Diagnostics GmbH | Jun 14, 2024 | Manufacturer | [PDF](https://www.fda.gov/media/195459/download?ref=fdaweb.com) | | GSK Vaccines GmbH | Mar 06, 2024 | Licensed Biological Drug Manufacturer | [PDF](https://www.fda.gov/media/195482/download?ref=fdaweb.com) | | Biotest AG | Dec 15, 2023 | Drug Substance and Drug product Manufacturer | [PDF](https://www.fda.gov/media/195473/download?ref=fdaweb.com) | | Sanofi Pasteur | Sep 29, 2023 | Vaccine Manufacturer | [PDF](https://www.fda.gov/media/195485/download?ref=fdaweb.com) | | IDT Biologika GmbH | Sep 08, 2023 | Vaccine Manufacturer | [PDF](https://www.fda.gov/media/195507/download?ref=fdaweb.com) | | Burgwedel Biotech GmbH | Aug 29, 2023 | Biologics Vaccine Manufacturer | [PDF](https://www.fda.gov/media/195495/download?ref=fdaweb.com) | | Charles River Laboratories Inc | Aug 25, 2023 | Manufacturer | [PDF](https://www.fda.gov/media/195584/download?ref=fdaweb.com) | | Seqirus Vaccines Limited | May 26, 2023 | Vaccine Manufacturer | [PDF](https://www.fda.gov/media/195487/download?ref=fdaweb.com) | | Konrad Rejdak, M.D. | May 19, 2023 | Clinical Investigator | [PDF](https://www.fda.gov/media/195476/download?ref=fdaweb.com) | | SciVac LTD | Mar 27, 2023 | Sterile Drug Manufacturer | [PDF](https://www.fda.gov/media/195468/download?ref=fdaweb.com) | | Octapharma Produktionsgesellschaft Deutschland mbH. | Mar 21, 2023 | Drug Substance Manufacturer | [PDF](https://www.fda.gov/media/195479/download?ref=fdaweb.com) | | Dynavax GmbH | Feb 03, 2023 | Bulk Drug Substance Manufacturer | [PDF](https://www.fda.gov/media/195490/download?ref=fdaweb.com) | | Fin Vector Oy | Sep 27, 2022 | Drug Substance and Drug product Manufacturer | [PDF](https://www.fda.gov/media/195551/download?ref=fdaweb.com) | | Protherics UK Ltd. | Jun 23, 2022 | Manufacturer | [PDF](https://www.fda.gov/media/195455/download?ref=fdaweb.com) | | ID Biomedical Corporation of Quebec | May 20, 2022 | Licensed Biological Drug Manufacturer | [PDF](https://www.fda.gov/media/195491/download?ref=fdaweb.com) | | Serum Institute of India Pvt. Ltd. | Apr 19, 2022 | Biological Manufacturer | [PDF](https://www.fda.gov/media/195499/download?ref=fdaweb.com) | | SIAM STERI SERVICES CO., LTD | Aug 23, 2019 | Contract Sterilizer | Pending | | GlaxoSmithKline Biologicals SA | Jun 24, 2019 | Vaccine Manufacturer | Pending | | Pliva Croatia Ltd. c/o Teva Pharmaceuticals, USA | May 31, 2018 | Analytical facility | Pending |