PMS4PMS, LLC — FDA Warning Letter Findings

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). You lacked a quality unit (QU) with appropriate oversight for the manufacture of your over-the-counter (OTC) topical analgesic drug product. For example, your QU failed to ensure: Adequate procedures were written and followed describing the…

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)). Your firm failed to adequately determine the appropriate laboratory testing necessary for your OTC drug product. For example, you did not perform testing for identity and strength of the active ingredient prior to release and distribution. We acknowledge that you do not intend to continue manufacturing the “Comforté® Menstrual Cramp RELIEF CREAM” drug product. However, you failed to address the lack of testing of your drug product on the market that is still within expiry. Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)). You failed to establish and maintain an adequate stability testing program to support the labeled expiry on your distributed drug products. There is no assurance that your drug products will remain acceptable throughout the assigned 5-year expiry period without an ongoing stability program. For products without appropriate stability studies, there is insufficient scientific evidence to support that the drug products will meet established specifications and retain their quality attributes through their assigned expiry.