FDA WARNING_LETTER - Avlon Industries, Inc. - January 24, 2023

The FDA issued a Warning Letter to Avlon Industries, Inc. following a January 17-24, 2023 inspection of their Melrose Park, IL drug manufacturing facility, identifying significant Current Good Manufacturing Practice (CGMP) violations. The firm's drug products are deemed adulterated due to non-conforming manufacturing methods, facilities, or controls.

Key violations include: 1. **Failure to test components:** The firm did not conduct identity testing for incoming drug product components (e.g., active ingredients, glycerin, water) and improperly relied on unqualified supplier Certificates of Analysis (COAs). This is particularly critical for high-risk components like glycerin and propylene glycol, which require specific USP identity tests to detect hazardous impurities like diethylene glycol (DEG) or ethylene glycol (EG). 2. **Inadequate production and process controls:** The firm lacked process validation for OTC drug manufacturing, failing to demonstrate reproducibility and consistent quality. They also failed to perform cleaning validation for equipment used for both pharmaceutical and non-pharmaceutical products, a repeat observation from a 2017 inspection. Additionally, the water system used for drug manufacturing was not qualified or adequately monitored, also a repeat observation. 3. **Quality Control Unit (QCU) deficiencies:** The QCU failed to provide adequate oversight, with multiple CGMP-related documents incomplete, indicating a lack of responsibility in ensuring drug product compliance.

The FDA deemed the firm's February