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

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 in at least four cases, and did not conduct quality audits often enough or document the investigations in full, the agency found. The facility did not investigate complaints of possible device failures in 10 cases, and lacked full documentation in six more cases.