ABCO Laboratories, Inc. – FDA 483, Mar 10, 2020

ABCO Laboratories, Inc. in Fairfield, CA, a contract manufacturer of over-the-counter drugs, received a Form 483 with three observations. The inspection revealed deficiencies in laboratory controls, specifically the failure to perform required analytical and microbiological testing, and issues with the quality control unit's procedures, including the lack of qualification for a third-party testing laboratory. Additionally, the firm failed to conduct annual product reviews for its OTC drug products.