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Many medical device firms receive Form 483 citations from the FDA because of issues related to quality audits, corrective and preventive actions, employee training records, documentation control, etc. In this question-and-answer white paper—FDA Medical Device Investigator Offers Insights on Inspection—MasterControl interviews a medical device specialist with the FDA's Office of Regulatory Affairs, who has been inspecting domestic and international medical device companies for the past 12 years. Information: www.mastercontrol.com.


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