FDAnews Device Daily Bulletin

FDA Hits Oakworks Over Unreported Changes, Record-Keeping, Complaints

May 30, 2017

The FDA hit device manufacturer Oakworks for unreported product changes, verification issues and failure to investigate complaints.

Following a March 2017 inspection of the company’s New Freedom, Pennsylvania, facility, the agency issued a Form 483. According to inspectors, the firm made alterations to devices without reporting the changes in writing to the FDA, and the company took several months to update the owners’ manuals.

The company also failed to submit timely reports on device malfunctions at least four cases, and did not conduct quality audits often enough or document the investigations in full, the agency found.  Oakworks also did not sufficiently document its corrective and preventive actions, which the form noted was a repeat observation.

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