FDA: Drugmakers Should See Shadow Factories as Warning

The FDA is warning manufacturers about the dangers of suppliers that use show-and-shadow factory arrangements, but the industry may not be getting the message, experts say.

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