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# CGMP Violations in Shanghai Weierya Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-shanghai-weierya-inspection/
- Published: 2018-02-27T12:00:00.000Z
- Updated: 2026-09-14T23:25:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140855

A 4/10-4/14/17 FDA inspection at Shanghai Weierya Daily Chemicals Factory, Shanghai, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/7 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597899.htm?ref=fdaweb.com). Specific violations cited in the letter were: 

- failing to have for each batch of drug product appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable organisms;
- failing to ensure the identity of components, including active ingredients and excipients, from various suppliers; and
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA says the firm’s response to the inspection observations was inadequate in that it did not provide sufficient evidence that the company is taking corrective actions to bring its operation into full compliance with CGMP. The agency also says that significant inspection findings indicate that the company’s quality unit is not able to fully exercise its responsibilities. And it reminds the company that it is responsible for the quality of the drugs it produces as a contract facility, regardless of any agreements in place with product owners. The letter recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements.

The firm was placed on an FDA import alert 9/14/17\. It was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.