FDA 483 - Time-Cap Laboratories, Inc. - December 18, 2019

Time-Cap Laboratories, Inc. in Farmingdale, NY, a drug manufacturer and repackager, received a Form FDA 483 with three observations during an inspection from December 5-18, 2019. The firm was cited for inadequate cleaning validation processes for shared equipment, a lack of written procedures for the quality control unit, and failures in reviewing and investigating unexplained discrepancies and audit trail actions. These findings highlight significant concerns regarding the firm's adherence to Good Manufacturing Practices and data integrity.