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.
The inspector found the firm had not established written medical device reporting procedures or procedures to adequately control produce that did not conform to specified requirements.
For example, a number of nonconformances failed to document the lot number of the affected products, and the nonconformance “did not have a documented root cause as required by the firm’s procedures.”
Software used as part of the quality control system was not adequately validated for its intended use, the inspection revealed. The software was used to perform dimensional analysis on speculum components to ensure they meet specified requirements before being released for assembly.
The FDA also cited the firm for not establishing schedules for adjusting, cleaning and maintaining equipment. The 483 notes that preventive maintenance performed on injection molding machines was not included on the firm’s preventive maintenance schedule.