Compliance Management

FDA Issues Warning Letter to Chinese API Maker

Jun 22, 2017

FDA

The U.S. FDA issued a warning letter to API maker Qinhuangdao Zizhu Pharmaceutical for numerous data integrity issues found during an inspection of its Hebei province facility at the end of November last year. According to the FDA, employees manipulated date/time settings on their high performance liquid chromatography (HPLC) systems for undocumented reasons. The FDA inspectors also found that quality control analysts used a shared login account to access HPLC systems, and the company had disabled the audit trail feature on seven of the HPLC systems at the facility.

Although the company responded to the letter and promised revising procedures by September 2017, their response was insufficient because it did not specify who holds administrative privileges on their computers, nor did it address the significant pattern of data manipulation.

Read the warning letter