# FDA EIR - Medtronic Puerto Rico Operations Co. - October 25, 2019

Source: https://www.keypedia.com/records/eir/medtronic-puerto-rico-operations-co/878cf36f-5a41-4cbc-ba8c-9636891d0c6a

> FDA EIR for Medtronic Puerto Rico Operations Co. on October 25, 2019. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Medtronic Puerto Rico Operations Co.
- Inspection Date: 2019-10-25
- Product Type: devices
- Summary: This FDA inspection of Medtronic Puerto Rico Operations Co. (MPROC), a manufacturer of Class II and Class III medical devices, took place from October 1 to October 25, 2019. This compliance follow-up inspection aimed to assess actions taken in response to a prior Warning Letter and For-Cause inspection in 2018. While many previously cited issues, including those related to corrective and preventive actions (CAPA), process validation, and rework activities, were deemed adequately addressed, the current inspection identified several new objectionable conditions documented on an FDA-483 form.Key violations concerned systemic deficiencies within MPROC's quality management system. These included inadequate CAPA investigations failing to thoroughly analyze root causes for bioburden and endotoxin failures in implantable spinal infusion pumps. The firm's proposed corrective actions for internal supplier controls were also found to be disproportionate to the significance of historical quality data, such as non-conformances and quality holds. Further issues identified involved insufficient process validation activities to investigate encountered failures, inadequate procedures for managing rework and re-testing for non-conformities, and shortcomings in evaluating risk for non-conforming products and documenting product disposition. All observations were annotated by Medtronic management as "promised to correct," indicating their commitment to address the identified issues in accordance with the regulatory framework governing medical device manufacturing.

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