FDA 483 - Medtronic Puerto Rico Operations Co. - April 28, 2016

**FDA 483 Summary for Medtronic Puerto Rico Operations Co.**

**Inspection Dates:** April 5, 2016 - April 28, 2016 **Location:** Juncos, PR **Establishment Type:** Medical Device Manufacturer **FEI Number:** 3004639318 **Report Issued to:** Mr. Felix M. Negron, Vice President of Operations

**Main Violations/Issues:**

1. **Process Monitoring and Control:** The firm failed to establish adequate procedures for monitoring and controlling process parameters for validated processes. Specifically, the performance qualification reports for the sealing processes of implantable devices, such as Synchromed II infusion pumps, did not include necessary product testing to ensure continued compliance with device specifications.

2. **Acceptance Procedures:** The procedures for accepting in-process products were inadequate. The acceptance activities did not fully represent the device's functionality or operational range, particularly for Paradigm Insulin Infusion Pumps, resulting in potential non-compliance with critical product specifications.

3. **Corrective and Preventive Actions (CAPA):** The documentation of CAPA activities was insufficient. The firm did not adequately document the evaluation of reported problems or the implementation of corrective actions to address these issues.

**Regulatory Framework:** The observations are based on the FDA's quality system requirements, which mandate that manufacturers conduct internal audits to identify and correct violations.

**Required Actions:** Medtronic Puerto Rico Operations Co. must address the noted deficiencies by establishing comprehensive procedures for process validation, enhancing acceptance testing protocols, and ensuring thorough documentation of CAPA activities. The firm is responsible for conducting internal audits to rectify all quality system violations and may discuss corrective actions with FDA representatives.

**Contact Information:** For further inquiries or to submit corrective action plans, contact the FDA at the provided address and phone number.