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

Source: https://www.keypedia.com/records/483/biovation-orthopaedic-solutions-ltd/3b289d35-26b6-4ffd-b3c9-30070a15590d

> FDA 483 for Biovation Orthopaedic Solutions Ltd on February 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biovation Orthopaedic Solutions Ltd
- Inspection Date: 2019-02-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/biovation-orthopaedic-solutions-ltd/5fbf07bd-d7d4-491c-ab8a-126f6a4920c5

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd