AmLion Toothpaste Mfg. Sdn. Bhd. – FDA Warning Letter, Jul 14, 2023

The FDA inspected AmLion Toothpaste Mfg. Sdn. Bhd. from July 10-14, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drugs adulterated.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming components for identity, purity, strength, and quality, specifically failing to test high-risk components like glycerin and sorbitol for diethylene glycol (DEG) or ethylene glycol (EG) contamination. Supplier qualification was also inadequate, relying on questionnaires without validating test results. 2. **Inadequate Quality Control Unit (QU) oversight:** The QU lacked sufficient oversight, with In-Process Quality Control (IPQC) staff, reporting to general managers, approving manufacturing documentation without further QU review. Deviations were also not adequately investigated or documented. 3. **Insufficient stability testing program:** The firm lacked an adequate written stability program to determine appropriate storage conditions and expiration dates, including proper testing of active ingredients and impurities. Stability samples were stored in uncontrolled environments. 4. **Failure to validate processes:** Manufacturing processes for OTC drug products were not adequately validated. Investigators also observed white residue and rust on "clean" production equipment.

These are repeat observations from 2015 and 2018 inspections, indicating inadequate executive management oversight. The FDA recommends engaging a qualified CGMP consultant to conduct a comprehensive six-system audit.