Max Chemical Inc. – FDA Warning Letter, Mar 15, 2024

The FDA inspected Max Chemical Inc. in San Juan, Puerto Rico, from March 11-15, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The company's April 3, 2024, response to the FDA 483 was deemed inadequate due to insufficient documentation and evidence of corrective actions.

Key violations include: 1. Failure to test samples of each component for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)), relying on unverified supplier COAs for active ingredients like isopropyl and ethyl alcohol. 2. Failure to establish written procedures for production and process control (21 CFR 211.100(a)), specifically regarding an inadequately qualified and monitored water system used in OTC drug products. 3. The quality control unit failed to ensure CGMP compliance and adherence to specifications (21 CFR 211.22), lacking oversight in finished product testing, stability programs, investigation of in-process testing failures, and employee training.

Max Chemical Inc. has committed to ceasing drug production. If they resume, they must notify the FDA and engage a qualified consultant (21