# FDA 483 - BWXT Medical Ltd - February 23, 2024

Source: https://www.keypedia.com/records/483/bwxt-medical-ltd/9447e311-4757-4fcc-bc1f-a649a7ddbb6e

> FDA 483 for BWXT Medical Ltd on February 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BWXT Medical Ltd
- Inspection Date: 2024-02-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: BWXT Medical Ltd, a radiochemicals API manufacturer in Vancouver, British Columbia, was cited for inadequate procedures to ensure correct labeling of API products. The inspection revealed repeated instances of erroneously pre-printed vial labels, attributed to human error and a quality control unit's failure to detail standard operating procedures sufficiently. This indicates a significant issue with label control and quality assurance processes.

## Related Documents

- [483 - 2022-01-28](https://www.keypedia.com/records/483/bwxt-medical-ltd/715a3356-9dd1-4d67-888a-d6f569ef1e70)

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/bwxt-medical-ltd/020d2f7a-bcde-4c0d-ade0-6aaf88ce6110

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1