Lessons from FDA 483s and cGMP Inspection Data

Abstract

FDA recorded a total of 2997 audit observations in 2014, including 645 Form 483s issued for finished formulation and API sites, which, in turn, were classified into nine categories (4): * Subpart B, organization and personnel * Subpart C, buildings and facilities * Subpart D, equipment * Subpart E, control of components and drug product containers and closures * Subpart F, production and process controls * Subpart G, packaging and labeling control * Subpart H, holding and distribution * Subpart I, laboratory controls * Subpart J, records and reports. The highest number of observations were related to Subpart I-laboratory controls and Subpart J-records and reports, Subpart F-production and process controls, Subpart B-organization and personnel, and Subpart D-equipment. FDA, Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency by Promoting Greater Access to the Agency's Compliance and Enforcement, FDA Data Transparency Task Force, US Department of Health and Human Services (2011).