[Date: May 5, 2025]

The FDA has issued warning letters to 15 supplement manufacturers for significant violations found during recent facility inspections. The violations include inadequate quality control procedures, failure to establish proper product specifications, and improper testing methods.

Among the cited issues were insufficient cleaning protocols between production runs, inadequate testing of incoming raw materials, and failure to maintain proper documentation of manufacturing processes. Several companies were also cited for making drug claims on supplement products.

Companies have 15 business days to respond with plans to address the violations. Failure to correct these issues may result in product seizures, injunctions, or other enforcement actions.

Source: FDA