Loading…
Yusef Manufacturing Laboratories, LLC received this warning for manufacturing adulterated over-the-counter drug products, including hand sanitizers, due to significant Current Good Manufacturing Practice (CGMP) violations. The company failed to conduct required identity tests on incoming components and did not validate or establish the reliability of supplier test analyses at appropriate intervals, instead relying solely on unqualified suppliers' certificates of analysis. Specifically, the firm accepted ethanol for hand sanitizer manufacturing based only on visual and olfactory inspection without performing adequate testing for identity, purity, strength, and quality. These failures meant the company could not ensure that incoming components met appropriate specifications, rendering their finished drug products adulterated under federal law.