FDA Warning Letter for not answering a Request for Inspection

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We recently reported on a case in which the failure to respond to FDA requests led to a Warning Letter. The U.S. Food and Drug Administration (FDA) has now published another incident that also goes in this direction.

The new Warning Letter dated 22 January 2024 was sent to a company located in Thailand, which is registered as an API manufacturer.

The FDA had planned an inspection from 18 to 22 September 2023. The FDA attempted communication via email and contact with the U.S. Agent, but all efforts were unsuccessful. As a result, the company's drugs are considered adulterated under section 501(j) of the FD&C Act due to hindering the inspection process.

The firm was placed on Import Alert 55-03 on 18 January 2024. The FDA warns that approval of new applications or supplements listing the company as a drug manufacturer may be withheld until compliance with Current Good Manufacturing Practice (CGMP) is confirmed through inspection.

The letter requires the firm to respond within 15 working days, providing additional information or requesting an FDA inspection.

For further information, please see the complete Warning Letter to Mei Lan Thailand Co., Ltd. at the FDA website.