Chinese API Manufacturer Draws Warning Over Data Management
The FDA warned Lijiang Yinghua Biochemical and Pharmaceutical for serious data management failures and quality unit errors.
In an October 2017 inspection of company’s Lijiang, Yunnan facility, agency investigators found the facility did not adequately control access to data in computerized systems. For example, its high-performance chromatography and gas chromatography systems had a single username with administrative rights, allowing all users to modify or delete data files.
The facility had no established methods for tracing who made changes to the systems’ data, and the investigator observed that the firm had not performed corrective actions from an earlier inspection.
The facility conducted HPLC tests for an API for release to the U.S. between September and May 2017. When the agency requested the assay results, however, the firm said the data had been accidentally deleted.
