# FDA 483 - Medtronic Puerto Rico Operations Co. - February 21, 2019

Source: https://www.globalkeysolutions.net/records/483/medtronic-puerto-rico-operations-co/b8afb54c-6a6f-42e6-8d69-3c3bb84898c1

> FDA 483 for Medtronic Puerto Rico Operations Co. on February 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Puerto Rico Operations Co.
- Inspection Date: 2019-02-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Medtronic Puerto Rico Operations Co., a medical device manufacturer in Juncos, PR, revealed significant deficiencies in its quality system. The firm failed to establish timely corrective and preventive action procedures and did not adequately investigate complaints involving potential device failures. These issues indicate a lack of robust quality control processes for medical devices.

## Related Documents

- [483 - 2019-10-25](https://www.globalkeysolutions.net/records/483/medtronic-puerto-rico-operations-co/fb2a6d18-83e8-43d8-8a79-a19f9844043a)

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.globalkeysolutions.net/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.globalkeysolutions.net/companies/medtronic-puerto-rico-operations-co/9475f1c5-508a-4520-9cd7-c96839b4bffd

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