FDA Warning Letter to Drug Manufacturing Facility in Thailand

Recommendation

23-25 October 2024
Barcelona, Spain

GMP/FDA Compliance in Analytical Laboratories
How to implement cGMP requirements in the everyday practice of quality control laboratories

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated 27 February 2024 to a drug manufacturing facility in Thailand for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The violations were discovered during an inspection conducted from 31 July to 04 August 2023.

The violations include failure to conduct appropriate laboratory testing, as well as deficiencies in the quality control unit's oversight responsibilities:

• The firm failed to test drug product for identity and strength of active ingredients prior to release and distribution.
• QU failed to ensure that adequate cleaning and maintenance procedures are in place.
• GMP relevant data were not properly documented and retained.

The company committed to cease the drugs for the U.S. market. In the Warning Letter, the FDA requests clarification on the company's intention to resume manufacturing drugs for the U.S. market in the future. The authority emphasizes the need for the firm to engage a qualified consultant to assist in achieving CGMP compliance before resuming operations. The FDA warned that failure to address the violations could result in withholding approval of new applications or refusal of admission of articles manufactured by the company into the United States.

The company was given 15 working days to respond to the Warning Letter.

Fur further information, please see the complete Warning Letter on the FDA's Website.