FDA Warning Letter to Drug Manufacturing Facility in Thailand

The U.S. Food and Drug Administration (FDA) issued a Warning Letter on February 27, 2024, to a drug manufacturing facility in Thailand for serious violations of Current Good Manufacturing Practice (CGMP) regulations found during an inspection in July-August 2023. Violations include failure to conduct proper lab testing and deficiencies in the quality control unit's oversight:

• Neglecting to test drug products for active ingredient identity and strength before distribution.
• Inadequate cleaning and maintenance procedures oversight.
• Poor documentation and retention of GMP-relevant data.

The company agreed to halt distributing drugs to the U.S. market. The FDA seeks clarification on plans to resume U.S. drug manufacturing and urges hiring a consultant for CGMP compliance before restarting. Failure to address violations could lead to application approval withholdings or refusal of entry for articles into the U.S. The company has 15 days to respond. The complete Warning Letter is available on the FDA website.