# FDA 483 - Becton Dickinson Caribe LTD - March 11, 2020

Source: https://www.keypedia.com/records/483/becton-dickinson-caribe-ltd/10b4877a-480c-402f-8587-d27533d20c88

> FDA 483 for Becton Dickinson Caribe LTD on March 11, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Becton Dickinson Caribe LTD
- Inspection Date: 2020-03-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Becton Dickinson Caribe LTD in Cayey, PR, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, and also did not properly control nonconforming products. These issues indicate a lack of adherence to established quality system regulations.

## 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/efe78e51-a5ba-4c83-a406-709e73fad0b9

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