# FDA 483 - Becton Dickinson Caribe LTD - November 23, 2021

Source: https://www.keypedia.com/records/483/becton-dickinson-caribe-ltd/428e7ab3-82c7-4ed0-86ac-1b1f33121cad

> FDA 483 for Becton Dickinson Caribe LTD on November 23, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Becton Dickinson Caribe LTD
- Inspection Date: 2021-11-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Becton Dickinson Caribe LTD in Juncos, PR, was inspected from November 8-23, 2021, and received a Form FDA 483 with two observations. The inspection revealed inadequate corrective and preventive action procedures, specifically regarding device component content impacting test results and package integrity issues for distributed products. Additionally, the firm lacked proper documentation for the review and revalidation of processes in response to changes or deviations.

## Related Officers

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

Company: https://www.keypedia.com/companies/becton-dickinson-caribe-ltd/b9d097af-117b-477e-bf65-4b1a077936cd

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