FDA 483 - Coastal Contract Packaging, Inc - March 17, 2023

Coastal Contract Packaging, Inc. in Ventura, CA, was inspected by the FDA from March 13-17, 2023, and received a Form 483 with seven observations. The inspection revealed significant deficiencies in quality control, including failures to investigate out-of-specification results, use of unapproved batch records, lack of process and equipment validation, inadequate cleaning procedures, and insufficient component identity testing. Additionally, the firm failed to follow procedures for preventing objectionable microorganisms in drug products.