FDA Warning Letter to a Manufacturer of an Athlete Muscle Maintenance Creme

On 9 July, the FDA issued a Warning Letter to a Korean manufacturer registered as a manufacturer of over-the-counter drugs. With the Warning Letter, the FDA is responding to the documents it received from this manufacturer in response to two requests in 2022 and 2024. Since the methods, facilities or controls described in the company's response for the manufacture, processing, packaging or storage of drugs do not comply with CGMP, they are automatically considered adulterated and non-compliant.

Content
The Warning Letter lists a number of violations:
1. Lack of an adequate and written testing programme to assess stability properties. Only 3 months of data were available, with a shelf life of 2 years. There was therefore a lack of sufficient chemical and microbiological tests and data. This meant that there was no proof of compliance with the defined specifications and quality over the shelf life period.
2. The raw materials used had not been sufficiently tested with regard to identity and conformity, e.g. purity, starch and quality. This also included the error frequently identified in recent months that the batches of glycerine used were not tested for the limit values of diethylene glycol (DEG) and ethylene glycol. The FDA points this out again in its Warning Letter:

"The use of glycerin contaminated with DEG and EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.."

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