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# CGMP Violations Found at Zhejiang Bangli
- URL: https://www.fdaweb.com/cgmp-violations-found-at-zhejiang-bangli/
- Published: 2017-02-14T12:00:00.000Z
- Updated: 2026-09-14T22:06:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137971

An 8/16-8/17/16 FDA inspection at Zhejiang Bangli Medical Products, Yongkang City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 1/26 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm540251.htm?ref=fdaweb.com). The letter also indicates that the firm limited the agency’s inspection. Specific violations that were noted include: 

- 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, prior to release;
- failing to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality;
- failing to establish and follow written procedures for cleaning and maintaining equipment;
- failing to establish written procedures to prevent mix-ups and cross contamination by physical or spatial separation from operations on other drug products; and
- delaying, denying, or limiting an inspection or refusing to permit an FDA inspection.

The letter says that FDA collected samples of the firm’s product during an inspection of a customer’s facility and agency laboratory analysis showed that the samples were sub-potent for the labeled active ingredient, containing an average potency of 69% of the label claim.

If the firm resumes manufacturing drugs for the U.S. market, the letter says, FDA strongly recommends engaging a qualified consultant to help it meet CGMP requirements. The company was placed on import alerts on 9/7/16 and 9/9/16.

Until all violations are corrected and compliance with CGMP is confirmed, FDA says, the agency may withhold approval of any new applications or supplements listing the company as a drug manufacturer.

Zhejiang Bangli was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of each action.