FDA 483 - Medtronic Puerto Rico Operations Co. - October 25, 2019

The FDA conducted an inspection of Medtronic Puerto Rico Operations Co., a medical device manufacturer located in Juncos, Puerto Rico, from October 1 to October 25, 2019. The inspection revealed several significant issues primarily related to the company's corrective and preventive action (CAPA) procedures and validation processes.

Key violations included inadequate establishment of corrective and preventive action procedures. Specifically, investigations into corrective actions did not thoroughly analyze all contributing factors, particularly concerning the Synchromed implantable sterile infusion pump devices. The investigations failed to identify all underlying manufacturing processes affecting essential product specifications.

Additionally, the implementation of corrective actions related to purchasing controls was found lacking. CAPA 396748, initiated to address internal supplier control deficiencies, did not fully comply with purchasing controls and lacked a clear definition of roles and responsibilities. The corrective actions were delayed and not expected to be finalized until 2021, three years after initiation.

Furthermore, the inspection noted that processes whose results could not be fully verified by subsequent inspection and testing were not adequately validated. The evaluation of confirmed failures during validation activities did not encompass a thorough rationale for root causes.

Medtronic is required to conduct internal audits to identify and correct these violations, ensuring compliance with quality system requirements. The company is also expected to address these observations promptly, implementing effective corrective actions to prevent recurrence.