FDA Posts 172 Additional Inspection Records

FDA has begun releasing large batches of Form FDA-483 inspection reports under its 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.

To address that shortcoming, FDA Webview has compiled and organized by posting date all 172 Form 483 records released 10/19 through 10/22, supplementing its earlier report on 26 additional records posted Friday. Together, the two reports account for all 198 Form 483 records posted during the first week of large-scale releases, with establishment names, inspection dates and links to available FDA documents. The Form 483s contain investigators' observations, not final agency determinations of regulatory violations.

Source: FDA OII FOIA Electronic Reading Room. Nine records are listed without verified direct PDF links.