FDA issues Warning Letter to Canadian OTC Manufacturer

A Canadian OTC drug manufacturer received a Warning Letter from the U.S. FDA for significant violations of CGMP regulations. The firm produces hand sanitizer gel and burn/scar cream.

The FDA's March 27, 2024 document highlighted various violations:

• Inadequate testing to verify component identity.
• Failure to test ethanol lots for methanol.
• Insufficient testing of finished products for active ingredient content and impurities.
• Lack of production process validation and written procedures.
• Incomplete batch production and control records.

Two products were considered unapproved new drugs due to claims on labels and the website.

The FDA advises hiring a consultant to ensure compliance if the firm resumes U.S. drug manufacturing. The company has 15 days to respond, detailing corrective actions, or face further regulatory measures.

For more details, refer to the complete Warning Letter to Bodywell Natural Skin Care Inc. on the FDA website.