FDA 483 - Advanced Cosmetic Research Laboratories, Inc. - July 24, 2023

An FDA inspection of Advanced Cosmetic Research Laboratories, Inc. in Chatsworth, CA, revealed significant deficiencies in their drug manufacturing operations. The firm was cited for a lack of qualified personnel, inadequate investigations into out-of-specification results, and premature batch record approvals. Additionally, issues included unvalidated cleaning processes, poor facility maintenance, absence of process validation, and insufficient testing and qualification of components and suppliers.