Specifications Developer Cited for Failing to Report Field Correction, MDRs
Craftmatic Industries has been written up in a Form 483 inspection report for failing to submit a field report and medical device reports (MDRs) to the FDA, among other lapses.
During an inspection of the company’s Pompano Beach, Fla., facility, the FDA found that Craftmatic failed to submit a written report to the agency about a field correction performed in 2017 after the company received more than 45 complaints related to its adjustable home use bed. The bed base separated, causing users to fall, according to the Form 483.
The agency noted that roughly 88 percent of customer complaints were related to the bed’s adjustable base, but the firm failed to request a corrective action by the supplier.