Inspections and Audits

Genentech Chided for Poor Building Conditions

Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More

Drug Recalls Spike 17 Percent in 2013

The number of drug recalls shot up 17 percent in 2013 compared to 2012, despite the FDA’s best efforts to promote quality-by-design programs and upgrades to facilities. Read More

Indian Hospira Plant Gets Extensive Form 483

Sterile injectables maker Hospira was hit with a new Form 483 containing nearly two dozen observations after FDA investigators followed up an October 2012 inspection that uncovered inadequate sanitization procedures at its Irungattukottai, India, manufacturing plant. Read More