FDA Releases 79 More Form 483 Inspection Records

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), 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.