Keystone Topicals In Violation

摘要

An August 2012 inspection of Keystone Laboratories Inc.'s Memphis, Tenn., facility uncovered violations of good manufacturing practices for drug products, violative OTC products, and drug registration and listing violations, FDA says. Among the GMP violations detailed in a March 18 warning letter, Keystone's plant was found to be in disrepair, with leaking ceilings and peeling paint. Additionally, FDA found production equipment "with visible build-up and filth" - a repeat violation from inspections in 2009 and 2011.