Laboratory diagnostic tests and affiliation with drug and device manufacturers have made labs a popular target for U.S. Food and Drug Administration (FDA) quality system inspection. Going through an FDA inspection can be an ordeal, especially if you are unprepared. And once the inspection ends, you may receive the dreaded Form 483 setting out the…
Dealing with the FDA: 12 Best Practices for Responding to a Form 483
by Glenn S. Demby | Mar 14, 2017 | Compliance Guidance-lca, Enforcement-lca, Lab Compliance Advisor