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 cGMPs, the May 11 form says.

Quasar hired a consultant to assist with establishing and implementing a quality system and conducting internal audits. But in hiring the consultant, the company failed to comply with the established supplier procedures and complete a supplier evaluation for nearly a year.
The GMP Letter