FDA Import Alert Leaves WHO Without a Source for Birth Control API
Following an FDA import alert placed on a Chinese API manufacturer early last month, the World Health Organization was left without a prequalified source for the birth control drug levonorgestrel, also known as Plan B.
An FDA inspection of a Qinhuangdao Zizhu Pharmaceutical facility in late November 2016 found failures in cGMPs, including breaches in data integrity related to quality testing.
In October 2015, a WHO prequalification team inspected the facility for levonorgestrel, mifepristone and ethinylestradiol APIs, finding at least five major deficiencies that were subsequently corrected. The WHO is planning another on-site inspection.
The WHO said it has not received any reports of quality issues from levonorgestrel tablets, and it has been in touch with the FDA and the manufacturer to discuss the matter. The facility’s prequalification status remains unchanged.