In Brief: Establishment inspection reports
This article was originally published in The Tan Sheet
Executive Summary
Establishment inspection reports: FDA automatically will provide inspected companies with a copy of the agency's final EIR, beginning in April. The EIR will be provided as soon as FDA has determined that the inspected facility is in compliance with agency guidelines. Previously, inspected firms had to file for the EIR through FDA's Freedom of Information Act office. The change comes in response to industry complaints that third parties could receive copies of the EIR before the inspected company through FoI...