FDA Warning Letter issued to Chinese OTC Manufacturer for Lack of Analytical Test Data

On July 8, 2024, the FDA issued a Warning Letter to YangZhou SuXiang Medical Instrument Co., Ltd., a Chinese OTC drug manufacturer. The letter, based on a review of the company's records, cites major CGMP violations:

- Identity Testing: The company did not properly test the identity of incoming components.

- Process Validation: Manufacturing processes were not validated or controlled, with incomplete validation reports. The Quality Unit did not ensure processes were validated before releasing OTC products to the U.S.

- Finished Product Testing: The company failed to provide test data proving that drug products were adequately tested before distribution.

The FDA stressed that proper testing and procedures are essential for drug safety and quality. The company must hire a CGMP consultant and undergo a comprehensive audit before resuming U.S. manufacturing. It has been placed on Import Alert 66-40, blocking its products from entering the U.S. The company has 15 working days to respond.

For more details, see the Warning Letter on the FDA's website.