FDAnews Device Daily Bulletin

Corium Fentanyl Patch Plant Is Slapped With a Form 483

May 18, 2009
The FDA cited Corium International’s fentanyl transdermal patch manufacturing operations with a Form 483 that included nine inspectional observations. The form was issued after an inspection of the company’s Grand Rapids, Mich., production facility this spring. Corium failed to establish control procedures to validate the performance of production operations. It did not always complete documentation of additional in-process product testing when changes were made to operational settings, according to the form.
Devices & Diagnostics Letter