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# CGMP Violations at Hangzhou Zhongbo
- URL: https://www.fdaweb.com/cgmp-violations-at-hangzhou-zhongbo/
- Published: 2019-02-05T12:00:00.000Z
- Updated: 2026-09-15T01:00:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143295

A 4/23-4/27/18 FDA inspection at Hangzhou Zhonbgo Industrial Co., Ltd., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 11/27/18 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630081.htm?ref=fdaweb.com) says the 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, prior to release;
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates; and
- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

The letter reminds the company that it is responsible for the quality of drugs produced as a contract facility, regardless of agreements in place with product owners. FDA also says the firm’s inspection history indicates that its quality unit is not able to fully exercise its authority and/or responsibilities. “Your firm must provide the quality unit with the appropriate authority, sufficient resources, and staff to carry out its responsibilities and consistently ensure drug quality,” the agency says.

The inspection observations were repeated from those cited in a 2016 inspection. FDA recommended that the company retain a qualified consultant to assist it in meeting CGMP requirements. The letter says the agency recommends that the consultant perform a comprehensive audit of its entire operation for CGMP compliance, and that it evaluate the sufficiency, completion, and effectiveness of any corrective actions and preventive actions the company has implemented, before pursuing resolution of compliance status with FDA.

Hangzhou Zhongbo was placed on import alert 9/28/18\. The company was told to respond with a list of specific steps it has taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.