FDA WARNING_LETTER - Cetylite Industries, Inc. - September 24, 2021

The FDA inspected Cetylite Industries Inc. (FEI 2242327) from September 20-24, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The company's October 14, 2021, response to the FDA Form 483 was deemed inadequate.

Violations include: 1. **Failure to establish adequate laboratory controls (21 CFR 211.160(b))**: Cetylite used a compendial method for aerosol instead of the correct one for Benzocaine, Butamben, and Tetracaine Hydrochloride Gel, a USP article, for their gel product. They also failed to validate an alternative method used for release testing since March 2019. The company's custom methods yielded differing results from the USP method, and no validation package was provided. 2. **Failure to thoroughly investigate OOS results (21 CFR 211.192)**: The firm inadequately investigated an Out-of-Specification (OOS) result for tetracaine HCl potency (114.7%, 115.2%) using an unvalidated method. Retesting with the USP method also yielded OOS results (118.9%, 118.3%). The company then retested using two additional methods to achieve