Title:US FDA Warning Letters of CAPA Violations: A Review
VOLUME: 7 ISSUE: 2
Author(s):Pavan Deshpande, Rutuja Agawane, Sarath C. Tatikola and Surenahalli G. Vasantharaju*
Affiliation:Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka
Keywords:CAPA, USFDA, warning letters, US healthcare, violations, regulated markets.
Abstract:United States Food and Drug Administration (USFDA) is a federal agency functioning
under United States Federal Executive Departments, which strives to regulate the food products
and drug substances being manufactured or brought into US market, upholding Quality and Safety
as prime goals. It takes care of its goals by inspecting firms which market products in the United
States. It chalks out good manufacturing procedures for obtaining quality end-products. Based on
inspections conducted and data collected thereby, those not abiding by rules shall be issued with
Warning Letters and marketing license shall be cancelled for those who fail to justify the warning
letter. This brings about discipline amongst manufacturers and sets a goal of quality that needs to
be achieved to survive in market.