483
Biovation Orthopaedic Solutions LtdBiovation Orthopaedic Solutions Ltd – FDA 483, Feb 14, 2019
Record Details
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.
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ID · 3b289d35-26b6-4ffd-b3c9-30070a15590d
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