FDA WARNING_LETTER - Mei Lan Thailand Co., Ltd. - September 22, 2023

The FDA issued a Warning Letter to Mei Lan (Thailand) Co., Ltd. (FEI 3012190301), an API manufacturer of crude (b)(4), located in Samut Sakhon, Thailand. The letter, dated January 22, 2024, stems from the firm's failure to permit a planned FDA inspection scheduled for September 18-22, 2023.

The FDA attempted to notify the firm of the inspection multiple times via email on May 23, June 6, June 21, and August 29, 2023, and also attempted to contact their U.S. Agent on August 25, 2023. A follow-up written request was sent via UPS and delivered on August 29, 2023. All attempts to communicate and schedule the inspection went unanswered.

This refusal to permit inspection constitutes a violation of section 501(j) of the FD&C Act, 21 U.S.C. 351(j), rendering the firm's drugs adulterated. As a result, the FDA placed Mei Lan (Thailand) Co., Ltd. on Import Alert 55-03 on January 18, 2024. The FDA will withhold approval of new applications or supplements listing the firm as a drug manufacturer until