The FDA issued a Form 483 to Hand Biomechanics, citing problems with its complaint process and failure to submit MDR reports.
The agency issued the form following a June/July inspection of the firm’s Sacramento, Calif., facility. Investigators found the company did not submit an MDR report within 30 days of receiving information suggesting its devices may have contributed to injuries or deaths.
The FDA found that in handling complaints, the firm failed to include all information required in its own complaint procedures. Furthermore, the firm’s process for package sealing was not properly validated and its processes were not revalidated in the wake of changes or process deviations.
The agency also faulted the company on its CAPA handling, finding 10 cases where it failed to prevent recurrences of quality problems.