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US FDA has sent warning letters to two Medtronic PLC facilities producing cardiac rhythm management devices that were the subject of high-risk recalls earlier this year. The agency alleges that the company's sites violated narrow portions of its Quality System Regulation.

The first missive, dated July 30 but released online Sept. 11, resulted from an FDA inspection of Medtronic's Cardiac Rhythm and Heart Failure business in Mounds View, Minn. A second letter, dated Aug. 23 and also posted Sept. 11, was issued after an unfavorable inspection of the firm's Puerto Rico Operations Company in Juncos, Puerto Rico.

Both facilities were inspected at roughly the same time this year: Mounds View from April 23-May 14, and Juncos from April 23-May 15. The inspections appear to have been triggered by class I recalls of the firm's Amplia, Compia, Viva, Evera, Claria  and Visia  CRM devices between January and March 2018. The products failed due to high-voltage arcing. (Also see "Medtronic Initiates Class I Recall For ICDs Due To Manufacturing Error" - Medtech Insight, 28 Feb, 2018.)

The Mounds View letter dinged the manufacturer for failing to establish adequate design transfer procedures. The firm also fell down on process change activities; specifically, the Mounds View site was not notified after the Juncos facility made changes to an unspecified process, in violation of company procedures.

Medtronic is the recipient of two warning letters following unfavorable FDA inspections at its Minnesota and Puerto Rico facilities. The missives were the only device-related letters released by the US agency this week.

Meanwhile, the letter sent to the Juncos site found that unspecified processes weren't validated for the company'sBlackwellimplantable cardiac defibrillators. The Puerto Rico facility also failed to document unspecified activities in device history records for the ICD products it makes.

Multiple response letters sent to FDA from Medtronic CEO Omar Ishrak were found by the agency to be adequate. However, FDA said the firm's responses to its FDA-483 inspectional observation forms must be verified during a follow-up inspection.

In a statement toMedtech Insight, Medtronic says it "continues to strive for higher quality throughout the organization by enhancing its systems, processes and accountability, and is committed to the highest quality for its products and therapies." The firm noted that it is "working closely with FDA" to resolve the issues.

From the editors of The Gray Sheet


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