FDA 483 - Max Chemical Inc - March 15, 2024

An FDA inspection of Max Chemical Inc., a human drug manufacturer, conducted from March 11-15, 2024, revealed multiple significant deficiencies related to Current Good Manufacturing Practices (cGMP). The firm produces Isopropyl Alcohol 70% and Hand Sanitizer. Key observations included the lack of validation, calibration, and proper maintenance for the water system used in all drug products and equipment cleaning. The Quality Control unit was found to lack independence from production, and standard operating procedures (SOPs) were undated, deficient, and not properly implemented or trained upon. Poor documentation practices, including alterations and missing information, were also noted. Max Chemical Inc. failed to perform essential identity and methanol limit testing on raw materials, relying on Certificates of Analysis without a robust supplier qualification program. Critical issues were identified in the firm's handling of discrepancies and out-of-specification results, with no formal documentation or investigation procedures. Additionally, the company lacked a written stability testing program to support the expiration dates of its drug products and failed to conduct appropriate final product testing to ensure conformance to specifications before distribution. Max Chemical Inc. is required to implement comprehensive corrective actions to address these systemic compliance issues.