AmLion Toothpaste Mfg. Sdn. Bhd.

Warning LetterOpen

Mr. Min Koon Koek Managing Director AmLion Toothpaste Mfg. Sdn. Bhd. Lot 4, Gate A, Jalan Teknologi 3/6, Seksyn 3 Taman Sains Selangor 47810 Petaling Jaya Selangor MalaysiaFEI 3006057298Issued Nov 17, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3006057298.

Letter Details

Firm: AmLion Toothpaste Mfg. Sdn. Bhd.
Location: Mr. Min Koon Koek Managing Director AmLion Toothpaste Mfg. Sdn. Bhd. Lot 4, Gate A, Jalan Teknologi 3/6, Seksyn 3 Taman Sains Selangor 47810 Petaling Jaya Selangor Malaysia
FEI Number: 3006057298
Country: Malaysia
Issue Date: November 17, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

AmLion Toothpaste Mfg. Sdn. Bhd., a Malaysian manufacturer of over-the-counter toothpaste products including children's formulations, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company's primary violations included failure to conduct identity testing on incoming components before manufacturing, inadequate supplier qualification, and failure to validate and establish the reliability of component suppliers' test analyses at appropriate intervals. Instead of performing required testing, the company relied solely on supplier questionnaires reviewed by purchasing personnel rather than the quality unit, and lacked documented supplier approval through proper quality channels. The FDA conducted an inspection from July 10-14, 2023, and issued the warning letter on November 17, 2023, following the company's August response to the inspection findings.

AmLion Toothpaste Mfg. Sdn. Bhd. FDA Warning Letter, November 17, 2023