TCT Nutraceuticals SDN. BHD — FDA Warning Letter Findings

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)). Based on the records and information provided, you lack an adequate stability testing program and supporting data to demonstrate that the chemical properties and microbiological attributes of your drug product…

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Based on the records and information provided, you did not demonstrate you conducted adequate finished drug product testing on your drug products. For example, the certificate of analysis (COA) reports that…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures Antibacterial Hand Sanitizer Gel. Based on the records and information provided, you did not demonstrate you are adequately testing the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate you are testing your active ingredient isopropyl alcohol for methanol. Without adequate testing you do not have scientific evidence that your raw materials conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality, including testing for the presence of methanol in isopropyl alcohol. The use of alcohol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol , at https://www.fda.gov/media/173005/download.