California Drug Manufacturer Sees a Form 483 for Untrained, Inexperienced Personnel

A litany of failures spanning inadequate personnel, manufacturing, cleaning and other lapses have resulted in the FDA serving a Form 483 to Advanced Cosmetic Research Laboratories (ACRL) following the agency’s July 2023 inspection of the Chatsworth, Calif., facility.

ACRL — identified on its website as a manufacturer and supplier of products ranging from analgesic drugs, skin creams, toothpaste and pet shampoo — was found by investigators to employ individuals who “lack the education, training and experience to perform their assigned functions” related to the manufacture, processing, packing and holding of a drug product, and not qualified to perform GMP functions.

Nine observations were cited on the 483, outlining deficiencies linked to the company’s laboratory, equipment, materials, production and quality system.

Read the Form 483 here.

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