FDA Warning Letter issued to a Manufacturer of an Athlete Muscle Maintenance Crème

On July 9, the FDA issued a Warning Letter to South Korean manufacturer reBom Co., Ltd. for non-compliance with CGMP standards. The letter cites issues found in responses to FDA requests from 2022 and 2024. Violations include:

1. Inadequate Stability Testing: The company provided only 3 months of data for products with a 2-year shelf life, lacking sufficient chemical and microbiological testing to prove compliance.
2. Insufficient Raw Material Testing: Raw materials, including glycerin, were not tested for identity, purity, and contaminants like diethylene glycol (DEG) and ethylene glycol (EG), which are linked to fatal poisoning.

The company failed to demonstrate proper testing for products like dermaFIT Athlete Muscle Maintenance Cream. The FDA recommends consulting a GMP expert and warns that new application approvals may be withheld until violations are resolved. Non-compliance could lead to denial of U.S. entry for their products.

For more details, see the FDA Warning Letter on their website.