FDA 483 - Cosmax USA, Inc. - July 22, 2022

An FDA inspection of Cosmax USA, Inc. in Solon, OH, revealed a significant deficiency in laboratory controls. Specifically, the firm failed to establish scientifically sound and appropriate test procedures, as method validations for stability testing of two drug products, Broad Spectrum SPF 40 and Sunscreen, did not demonstrate stability-indicating properties. This issue led to the release of numerous batches of these drug products without adequate assurance of their stability.