Complaint Evaluation Procedures Net Circle Prime Form 483

Circle Prime Manufacturing received a Form 483 after an FDA inspection revealed inadequate records, complaint procedures and a failure to describe its vendor rating criteria.

FDA inspectors visited Circle’s Cuyahoga Falls, Ohio, facility in March and listed seven issues, including a lack of procedures for capturing, managing, and investigating complaints. Specifically, the firm had no way to capture potential complaints if a product was not returned.

The agency also determined that records of acceptable suppliers, contractors, and consultants were not being adequately established, and found that Circle lacked documentation and procedures to describe criteria for determining an approved supplier’s rating or the potential ramifications of a “poor” rating. — Jeff Kinney