FDA 483 - Biovation Orthopaedic Solutions Ltd - February 14, 2019

The FDA inspected Biovation Orthopaedic Solutions Ltd and issued a Form 483 with four observations. The findings indicate deficiencies in quality system procedures, including inadequate supplier controls for calibration services and issues with corrective and preventive action (CAPA) procedures and documentation. Additionally, the firm failed to adequately maintain device history records, specifically regarding batch records for blister packaging.