FDA EIR - Cosmax USA, Inc. - July 22, 2022

An FDA inspection of CosMax USA, Inc. in Solon, OH, conducted from July 18-22, 2022, served as a follow-up to a previous warning letter. The inspection primarily focused on drug manufacturing operations, specifically cosmetics and sunscreens, and assessed the company's adherence to drug manufacturing regulations, particularly 21 CFR §211.160(b) concerning laboratory controls. The inspection identified a significant deficiency, resulting in a single observation on Form FDA 483. CosMax USA, Inc. was cited for using laboratory methods for stability testing that were not scientifically sound or proven to be stability-indicating. This included methods used for sunscreen products, a repeat observation from the prior inspection, indicating a persistent issue in ensuring product quality and purity over time. Additionally, inspectors verbally communicated a concern regarding incomplete manufacturing records, specifically the absence of all labeling specimens in packaging batch records for a specific SPF 30 lot. Company management acknowledged the observations and committed to implementing necessary corrective actions. They also pledged to submit a comprehensive written response addressing these findings within 15 business days of the inspection's conclusion.