FDA Releases Another 33 Form 483 Inspection Records

FDA published another 33 Form 483 inspection records on 10/27 through its Office of Inspections and Investigations FOIA Electronic Reading Room, including records involving Catalent, Janssen Biopharmaceuticals, Ferring Microbiome, Genzyme, Philips Medical Systems, Baxter and Grifols.

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.