> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Violations at Huaian Zongheng Bio-Tech
- URL: https://www.fdaweb.com/cgmp-violations-at-huaian-zongheng-bio-tech/
- Published: 2020-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:58:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145843

A 7/1-7/5 FDA inspection at Huaian Zongheng Bio-Tech Co., Huaian, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/9 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/huaian-zongheng-bio-tech-co-ltd-590789-01092020?ref=fdaweb.com) says specific violations were: 

- failing to have for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient;
- failing to conduct at least one test to verify the identity of each component of a drug product;
- 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 establish adequate written procedures for production and process control designed to assure that drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

The letter notes that the drugs produced contain glycerin as an ingredient and says that the use of glycerin contaminated with diethylene glycol has resulted in various lethal poisoning incidents in humans worldwide. It also reminds the company that it is responsible for the quality of the drugs it produces as a contract facility regardless of agreements in place with product owners.

Based on the nature of the violations, FDA strongly recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements and recommends that the consultant perform a comprehensive audit of the firm’s entire operation for CGMP compliance and evaluate the completion and efficacy of corrective and preventive actions before the company pursues resolution of its compliance status with FDA.

FDA placed Huaian Zongheng on Import Alert 11/8/19\. It told the company to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.