FDA EIR - Actavis Laboratories FL, Inc. - May 25, 2021

An FDA inspection of Actavis Laboratories FL, Inc. was conducted from May 5 to May 25, 2021, as a compliance follow-up to a previous warning letter and to assess current Good Manufacturing Practices (cGMP). The inspection encompassed several critical systems, including Quality, Production, Laboratory, Facilities and Equipment, and Materials, for the company's human, prescription generic oral drug products. The FDA issued a Form FDA-483, detailing five significant deficiencies. These included incomplete investigations into manufacturing discrepancies and batch failures, a lack of established procedures and microbial testing to prevent objectionable microorganisms in non-sterile oral drug products using purified water, and 147 pieces of active equipment found to be overdue for calibration. Additionally, master production and control records lacked comprehensive instructions for collecting finished drug product quality control samples, and complaint procedures were inadequate regarding the review of relevant data. Actavis's management was notified of the observations and reminded of their responsibility to ensure full compliance with regulatory requirements. The company is required to submit a written response outlining their corrective actions within 15 business days to avoid potential further regulatory actions from the FDA.