Another FDA Warning Letter Based on Review of Records

The U.S. Food and Drug Administration (FDA) issued a Warning Letter on 12 November 2024 to a Chinese manufacturer of over-the-counter (OTC) drug products, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations. The letter, published on the FDA's website on 3 December 2024, stems from a review of records submitted by the company in response to formal requests for records and other information pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

As seen in another recent FDA Warning Letter reported in the ECA newsletter, the cited violations highlight critical issues, including:

• Identity Testing: The company failed to conduct adequate identity testing for incoming raw materials used in drug production. Instead, it relied solely on supplier certificates of analysis (COAs) without verifying the reliability of these certificates at appropriate intervals.
• Specifications: The company did not establish appropriate specifications for the strength of the active ingredient in its drug products. It also failed to demonstrate that these specifications ensure the finished drug product maintains the active ingredient’s strength throughout its shelf life.
• Quality Unit Oversight: The firm’s quality unit (QU) was found to be ineffective in fulfilling its responsibilities to oversee and ensure the quality of drug manufacturing operations.

As a result of these violations, the FDA has placed the company on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"), effective 12 November 2024.

The full Warning Letter addressed to Zhejiang Uniquality Nursing Products Technology Co., Ltd., doing business as Zhejiang YouQuan Care Products Technology Co., Ltd., is available on the FDA's website.