FDA 483 - Pride Mobility Products Corp - October 17, 2008
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Pride Mobility Products Corp, a medical device manufacturer in Exeter, PA, was cited for multiple serious deficiencies related to its complaint handling, Medical Device Reporting (MDR), and corrective and preventive action (CAPA) systems. The inspection revealed failures to submit timely MDRs for deaths and serious injuries, inadequate resources for complaint investigations, and a lack of documented evaluations for numerous device failure complaints. These issues indicate significant problems in the firm's quality system and its ability to ensure device safety and compliance.
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