Kabana Skin Care LLC — FDA Warning Letter Findings

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm manufactures over the counter (OTC) drug products, including sunscreens and antibacterial hand sanitizers. You failed to adequately test…

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 failed to adequately test batches of your drug products before release and distribution. For example, you stated during the inspection that you did not perform chemical or microbiological tests on your finished drug products prior to release and distribution into the U.S. market. Appropriate release testing, including identity and strength testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have scientific evidence to support whether your drug products conform to appropriate specifications before release.

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 adequate quality oversight for the manufacture of your drug products. For example, you failed to ensure: Establishment of suitable quality oversight procedures (e.g., raw material handling, review of production records…