FDA Steps Up Form FDA-483 Disclosures ; 26 Records Posted

FDA has accelerated the public release of Form FDA-483 inspection records as part of its expanded transparency initiative (see earlier story), increasing the volume of inspection documents available through the agency's FOIA Electronic Reading Room.

On 10/23, the agency published 26 Form FDA-483 records covering pharmaceutical manufacturers, testing laboratories, medical device establishments and other FDA-regulated facilities.

Although FDA makes the records publicly available, its online Reading Room presents them in a paginated table that can make reviewing an entire day's disclosures cumbersome. For readers' convenience, FDA Webview has compiled all 26 records (see below) into a single listing with direct links to the original FDA documents.

All 26 records were published by FDA on 10/23, although the underlying inspections occurred on earlier dates, in some cases several years ago. The listing below provides the inspection date for each establishment and a direct link to its Form FDA-483. These observations represent investigators' findings and do not constitute final agency determinations.