# FDA 483 - Bard Shannon Limited - August 18, 2023

Source: https://www.globalkeysolutions.net/records/483/bard-shannon-limited/251bb236-df19-4443-b886-d0d75391eb7f

> FDA 483 for Bard Shannon Limited on August 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bard Shannon Limited
- Inspection Date: 2023-08-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Bard Shannon Limited in Humacao, PR, a medical device manufacturer, revealed three significant observations. The firm failed to adequately establish and follow procedures for environmental control, specifically cleaning manufacturing areas, which was a recurrent issue. Additionally, the inspection found deficiencies in supplier performance management and a lack of documented employee training records for critical procedures.

## Related Documents

- [483 - 2018-11-21](https://www.globalkeysolutions.net/records/483/bard-shannon-limited/bd4558d3-f90d-42b4-9c71-c19765e671e1)
- [483 - 2018-11-21](https://www.globalkeysolutions.net/records/483/bard-shannon-limited/8ddf4d17-86b7-4350-b41f-000d2d5086ef)

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/bard-shannon-limited/b5acb6e6-fd8b-4125-86ca-f353832e322c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6