# FDA 483 - Medtronic Puerto Rico Operations Co. - May 31, 2019

Source: https://www.globalkeysolutions.net/records/483/medtronic-puerto-rico-operations-co/b2482f60-b6b2-4d72-b510-f2a478a18f1c

> FDA 483 for Medtronic Puerto Rico Operations Co. on May 31, 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: 2019-05-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Medtronic Puerto Rico Operations Co. in Humacao, PR, was inspected and cited for significant deficiencies in its quality system, particularly concerning corrective and preventive actions, complaint investigations, nonconforming product control, and supplier quality management. The inspection revealed a pattern of inadequate investigations and controls related to component quality and device failures. These issues indicate a moderate level of severity in the firm's compliance with quality system requirements.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/medtronic-puerto-rico-operations-co/55b72cb0-3477-4cea-838d-1f3bd9e7833b

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