FDA Warning Letter for inadequate Batch Record Review
WHO`s Position on the Import Alert for a Chinese API Manufacturer`s Products
Qinhuangdao Zizhu Pharmaceutical Co. Ltd On WHO Public Inspection Report
The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.
Qinhuangdao Zizhu Pharmaceutical Receives FDA Warning Letter
Qinhuangdao Zizhu Pharmaceutical on Health Canada Inspection List
WHO Response to the USFDA import alert issued for Qinhuangdao Zizhu Pharmaceutical (API Manufacturing Site)
Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.
Enforcement Report - Week of April 19, 2017
The FDA’s decision to ban the products of a Chinese API maker has left the World Health Organization in the lurch trying to find another company to supply the ingredient for the birth control drug levonorgestrel.