33 More Form 483 Inspection Reports Posted
FDA has released 33 additional Form FDA-483 inspection reports on 10/30, covering drug and biologic manufacturers, medical device companies, and human tissue establishments in the U.S. and overseas.
The newly disclosed records include inspections of Baxter Healthcare, Catalent Maryland, Andelyn Biosciences, Charles River Laboratories, Autolus, AGC Biologics, GlaxoSmithKline Biologicals and Boehringer Ingelheim, among others.
Their availability is part of the agency’s expanded transparency initiative (see earlier story), 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. The complete listing appears below, with links to individual inspection documents where available.
Previous Form 483 posts can be viewed here.
| Establishment | Location | Establishment Type | FDA Document |
|---|---|---|---|
| Georgia Eye Bank, Inc. | Georgia | Human Tissue | Form FDA-483 |
| Fin Vector Oy | Finland | Drug Substance Manufacturer | Form FDA-483 |
| Baxter Healthcare Corporation | Illinois | Contract Laboratory | Form FDA-483 |
| Lake Superior Centre For Regenerative Medicine | Canada | Tissue Processor | Form FDA-483 |
| C.G. Laboratories, Inc. | Texas | HCT/Ps Testing Laboratory | Form FDA-483 |
| Elite Orthopedics, LLC | Missouri | HCTP Establishment | Form FDA-483 |
| Clongen Laboratories, LLC | Maryland | Release testing facility | Form FDA-483 |
| Lux Therapeutics LLC dba Ponya Therapeutics LLC | Georgia | Tissue Processor | Form FDA-483 |
| Andelyn Biosciences, Inc. | Ohio | Drug Substance Manufacturer | Form FDA-483 |
| Cardinal Biologicals, Inc. | Missouri | HCT/P Establishment | Form FDA-483 |
| Catalent Maryland, Inc. | Maryland | Biological Drug Product Manufactucer | Form FDA-483 |
| Indiana Coast Medical LLC | Indiana | HCT/P Distributor | Form FDA-483 |
| Lin, James P MD Inc. d.b.a. Reproductive Feritlity Center | California | Reproductive Human Tissue | Form FDA-483 |
| Incinta Fertility Center, LLC | California | HCT/P Reproductive Establishment | Form FDA-483 |
| Immucor, Inc. | Georgia | Medical Device Manufacturer | Form FDA-483 |
| Lions Medical Eye Bank & Research Center of Eastern VA | Virginia | HCT/P | Form FDA-483 |
| Charles River Laboratories | Tennessee | Cell Therapy Manufacturer | Form FDA-483 |
| InVia Fertility Specialists, PLLC | Illinois | Fertility Center | Form FDA-483 |
| Innovative Fertility Center | California | HCT/P Reproductive Establishment | Form FDA-483 |
| IndeCon, Inc. | Texas | HCT/P Distributor | Form FDA-483 |
| Foundation Medical LLC | Minnesota | Human Tissue Distributor | Form FDA-483 |
| Henogen SRL | Belgium | Viral Vector Manufacturer | Form FDA-483 |
| Fenwal International, Inc. | Puerto Rico | Manufacturer | Form FDA-483 |
| Autolus Limited (referred to as The Nucleus) | United Kingdom | Drug Substance and Drug product Manufacturer | Form FDA-483 |
| Medion Grifols Diagnostics AG | Switzerland | IVD Manufacturer | Form FDA-483 |
| Medimmune U.K. Limited | United Kingdom | Biologic Vaccine Drug Substance Manufacturer | Form FDA-483 |
| GlaxoSmithKline Biologicals | France | Manufacturer | Form FDA-483 |
| Boehringer lngelheim RCV GmbH & Co KG | Austria | Manufacturer | Form FDA-483 |
| AGC Biologics S.p.A. | Italy | Cell and Gene Therapy Manufacturer | Form FDA-483 |
| Medlmmune UK Limited (AstraZeneca/Supply Biologics) | United Kingdom | Vaccine Manufacturer | Form FDA-483 |
| CellTrans Islet Isolation facility | Illinois | cell and gene Therapy manufacture | Form FDA-483 |
| Laboratorio Banco Vida | Puerto Rico | Human Tissue Establishment | PDF pending verification |
| Duke University | North Carolina | Biologic Manufacturer | PDF pending verification |