Devicemakers Should Be Prepared to Share Audit Schedules

Results from company audits of suppliers are not available for FDA review, but devicemakers should be prepared to share audit schedules and other characteristics of the programs, according to an industry expert.

If a corrective and preventive action is opened because of a supplier audit, that action does need to be shared with the FDA, Steve Niedelman, senior consultant for Crowell & Moring, said at an FDAnews audioconference.

Fixing problems detected during audits shows that a company’s quality system is working, Niedelman said. “What it demonstrates to the FDA is that you have a rigorous program in place, that you are capturing your own problems and are addressing them, which is the whole purpose of the internal audits and the supplier audits,” he added.
The GMP Letter