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# CGMP Violations at China’s Hubei Kangzheng
- URL: https://www.fdaweb.com/cgmp-violations-at-chinas-hubei-kangzheng/
- Published: 2022-01-11T12:00:00.000Z
- Updated: 2026-09-14T17:28:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150903

A 6/16-6/24/21 FDA inspection at the Hubei Kangzheng Pharmaceutical Company drug manufacturing facility in Hubei Province, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/23/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hubei-kangzheng-pharmaceutical-co-ltd-616581-11232021?ref=fdaweb.com) says specific violations were: 

- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates;
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

The letter also references unapproved new drug and misbranding violations involving the company’s pi yen chin that is intended for use as an ophthalmic vasoconstrictor.

FDA acknowledges the company’s commitment to cease production of drugs for the U.S. market and asks the company to clarify whether it intends to resume manufacturing drugs for the U.S. market at its facility in the future. The company was placed on an import alert on 11/4/21.

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