FDA: Drugmakers Should See Shadow Factories as Warning
Suppliers using show-and-shadow factories show a clean, efficient facility to clients or investigators while manufacturing products in a factory with questionable regulatory compliance. The practice prompted two warning letters this year to Chinese drugmakers — Shanghai No. 1 Biochemical & Pharmaceutical and Quingdao Jiulong Biopharmaceuticals.
The arrangement should be an obvious indicator that a supplier is unfit, Deborah Autor, director of CDER’s Office of Compliance, said at FDAnews’ Fourth
Annual FDA Inspections Summit. However, some companies have asked the FDA how to get their suppliers to show them the shadow facilities, instead of switching
to another supplier, Autor said.
Drug GMP Report