FDA Issues Warning Letter for Critical CGMP and Data Integrity Violations in China

On 11 November 2025, the FDA published a Warning Letter issued on 9 October 2025 to Taizhou Kangping Medical Science and Technology Co., Ltd., citing extensive CGMP violations. The agency identified critical deficiencies in chromatographic practices and system suitability testing (SST), specifically noting that the firm’s HPLC assay method lacked appropriate SST checks per USP <621>. Analysts were instructed to construct standard curves only at long intervals, masking instrument drift and compromising assay accuracy.

Data integrity issues were also highlighted, including the use of unvalidated Excel spreadsheets for calculations, deletion of key files without audit trails, and shared access rights, violating ALCOA principles. These findings pose serious risks to assay reliability. Additional concerns included inadequate sterility controls and inconsistent product specifications.

FDA requested a thorough investigation, risk assessment, and a global CAPA plan addressing analytical controls, SST, and data governance. The company has recalled affected products distributed in the U.S.

The full Warning Letter is available on the FDA website.

24-11-2025