Quasar 483 Notes a Lack of Vetting Procedures

Quasar Bio-Tech did not establish and implement procedures for the manufacture and in-process control of electronic devices made by its contract manufacturer, according to a recent Form 483. The Sarasota, Fla., company also had not conducted site audits or maintained a contractual agreement with the contractor to determine if it was processing Quasar’s electronic devices according to good manufacturing practices, the May 11 form says.
The GMP Letter