FDA 483 - Avlon Industries, Inc - July 15, 2024

Avlon Industries, Inc. in Melrose Park, IL, was inspected for its OTC drug manufacturing operations and received a Form 483 with 10 observations, many of which are repeat findings. The inspection revealed significant deficiencies across quality control, including inadequate laboratory controls for water systems with repeated Burkholderia cepacia recovery, a lack of thorough investigations into discrepancies and out-of-specification results, and a failure to establish and follow critical quality unit procedures. Additionally, the firm lacked validated test methods, process and cleaning validations, equipment qualifications, and proper stability studies, indicating a systemic breakdown in their quality management system.