FDA 483 - Max Chemical Inc - March 15, 2024

Max Chemical Inc. in San Juan, PR, a human drug manufacturer of Isopropyl Alcohol 70% and Hand Sanitizer, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies across multiple quality systems, including inadequate equipment validation, a non-independent quality unit, insufficient raw material testing, and a lack of stability testing and proper product release procedures. These issues indicate a broad failure to adhere to current Good Manufacturing Practices.