FDA Hits Chinese API Manufacturer for Testing Violations

The FDA cited API manufacturer Shandong Zouping Dazhan New Materials after a January inspection of the firm’s Shandong facility revealed significant testing and other violations.

The investigator found the facility did not test incoming raw materials for identity before releasing them for production.

One of the raw materials only underwent a visual test. A manager said the material was given an additional in-use test. But the requirement for the in-use test was not included in the material specification and it was performed by a non-GMP research and development laboratory, the investigator found.