West Coast Cosmetics Inc – FDA 483, Mar 9, 2022

West Coast Cosmetics Inc., a drug manufacturer in Chatsworth, CA, was cited for significant deficiencies during an FDA inspection. The firm lacks a functional quality control unit, failed to conduct investigations into out-of-specification results, and did not establish expiration dates based on stability data for its drug products. Additionally, the company failed to set time limits for in-process hold times, a repeated observation from a previous inspection.