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# CGMP Violations at Taizhou Kangping
- URL: https://www.fdaweb.com/cgmp-violations-at-taizhou-kangping/
- Published: 2025-11-11T12:00:00.000Z
- Updated: 2026-09-14T15:26:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160198

A 3/10-3/14 FDA inspection at the Taizhou Kangping Medical Science and Technology Co. drug manufacturing facility in Jiangsu, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished over-the-counter drugs. A just-released 10/9 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/taizhou-kangping-medical-science-and-technology-co-ltd-711081-10092025?ref=fdaweb.com) says the specific violations were:

- failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile; and
- failure to establish appropriate product specifications and scientifically sound testing procedures.

The letter acknowledges the firm’s commitment to cease the commercial distribution of over-the-counter products in the U.S. market and cautions that FDA is to be notified before the resumption of any manufacturing for the U.S. market. FDA also acknowledges the firm’s decision to recall all of a redacted product that is within expiry. FDA says it placed all of the company’s drugs and drug products on a 9/18 import alert.

Taizhou was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.