Clinical Resolution Laboratory Inc. — FDA Warning Letter Findings

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). You released your OTC topical drug products prior to completing and reviewing all quality control testing. Specifically, your (b)(4) , Lot No. (b)(4) was released by your quality unit on July 2, 2020. However…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You did not validate the cleaning processes used for cleaning non-dedicated manufacturing equipment, such as Mixing Tank (b)(4) , which is used for your human drug and cosmetic products. Additionally, your practice of evaluating cleaning effectiveness for microbiological contamination via (b)(4) testing for (b)(4) was not validated. Inadequate…

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). You failed to provide data to demonstrate that the manufacturing processes for your OTC drug products have been validated. During the inspection, you were unable to provide documentation to support manufacturing…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm lacked an adequate quality unit (QU). For example, your quality unit failed to establish procedures describing QU roles, responsibilities, and authorities. Furthermore, your QU’s oversight of your drug manufacturing operations was…