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

Practical Statistical Tools for Analytical Laboratories

Recommendation

1/2 October 2024
Barcelona, Spain

Practical Statistical Tools for Analytical Laboratories
Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese company. The facility in question is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. The letter, dated 08 July 2024, is based on a review of records the company submitted in response to a formal FDA request for records and other information.

Following the review of these records, the FDA observed significant violations of Current Good Manufacturing Practice (CGMP) regulations, including the following:

Identity testing: The firm did not demonstrate that it is adequately testing the identity of incoming components used in the manufacture of drug products.
Process validation: The firm did not demonstrate that the manufacturing processes are reproducible and controlled to yield a product of uniform character and quality. The manufacturing process validation reports were incomplete. Furthermore, the "Quality Unit (QU) did not ensure that [the] manufacturing processes were adequately validated and in a state of control before releasing [the] OTC products for distribution to the U.S. market."
Finished drug product testing: Analytical test data to demonstrate that the drug products were adequately tested before release for distribution were not provided.

The FDA emphasizes that without proper testing and procedures, the safety and quality of the drug products cannot be assured. The company is advised to hire a CGMP consultant to address these violations and undergo a comprehensive audit before resuming drug manufacturing for the U.S. market. The FDA has placed the firm on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"), barring its products from entering the United States. The company has 15 working days to respond with corrective actions.

For more details, you can read the full Warning Letter sent to YangZhou SuXiang Medical Instrument Co., Ltd. on the FDA's website.