# FDA 483 - Bard Shannon Limited - November 21, 2018

Source: https://www.globalkeysolutions.net/records/483/bard-shannon-limited/8ddf4d17-86b7-4350-b41f-000d2d5086ef

> FDA 483 for Bard Shannon Limited on November 21, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bard Shannon Limited
- Inspection Date: 2018-11-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: BARD SHANNON LIMITED, a medical device manufacturer in Humacao, PR, was cited with eight observations during an FDA inspection from October 22 to November 21, 2018. The inspection revealed significant deficiencies across its quality system, particularly concerning corrective and preventive actions, production process controls, validation procedures, environmental controls, acceptance activities, equipment maintenance, and device history records. These issues indicate a systemic failure to adhere to established procedures and ensure product quality and safety.

## Related Documents

- [483 - 2018-11-21](https://www.globalkeysolutions.net/records/483/bard-shannon-limited/bd4558d3-f90d-42b4-9c71-c19765e671e1)
- [483 - 2023-08-18](https://www.globalkeysolutions.net/records/483/bard-shannon-limited/251bb236-df19-4443-b886-d0d75391eb7f)

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)
- [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