AmLion Toothpaste Mfg. Sdn. Bhd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 3

You failed to establish and follow an adequate written stability program to determine appropriate storage conditions and expiration dates of drug products manufactured at your facility. For example, your stability program lacked appropriate testing of your drug products, including testing of active ingredients, impurities, and other degradation products. Additionally, stability samples are stored inside a room that lacks temperature and humidity controls.

Passage 4

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).