by David R. Butcher
Marketing Communications, MasterControl
When an FDA investigator issues a Form 483 after inspecting your facility, the cited observations should be addressed in writing to the FDA within 15 days, even if the initial response will be preliminary. To prepare an appropriate response to the audit findings and get on the necessary path to mitigate and resolve the identified issues, you’ll want to focus on at least three key areas, according to ARC Experts President and CEO Walt Murray.
In the final installment of a three-part webinar series on FDA inspections, Murray, a consultant with more than 30 years of experience in quality management and regulatory affairs, recently explained how quality managers can successfully organize an internal response team, manage the corrective and preventive action (CAPA) process and ultimately provide a proper post-inspection FDA response.