The FDA hit Aero Data Metal Crafters for inadequate complaint procedures and device history records.
The agency issued a Form 483 to the devicemaker following a June inspection of its Ronkonkoma, NY, facility. According to investigators, the facility did not have medical device reporting procedures for its mammography positioning chair model MPC1000-E, a class I device.
The firm also did not maintain paper or scanned copies of the signed and reviewed device history records for the MPC1000-E, and did not keep labeling records for the device.
The agency also faulted Aero Data on its handling of complaints, noting that its complaint SOPs did not specify the procedure for receipt, review, evaluation and documentation to determine whether CAPAs were necessary.