Failing to establish procedures to review and evaluate complaints as well as CAPA procedures landed Alliance Precision Plastics a six-item FDA Form 483 following a March 28 to 30 inspection of its Rochester, New York, facility.
Alliance’s CAPA procedures didn’t include requirements to verify or validate corrective actions to ensure they don’t adversely affect the finished device. The firm does custom injection molding and mold design as well as contract assembly for original equipment manufacturers.
The firm’s procedure for customer complaints did not gather enough detail to ensure they were processed in a uniform manner. For example, the procedure didn’t include requirements to document the complainant’s name, address, phone number or the nature and details of the complaint, results of an investigation, device identification or any reply to the complainant, the agency said.