Greatbatch Medical S. De R.L. De C.V.August 15, 2019

FDA 483 - Greatbatch Medical S. De R.L. De C.V. - August 15, 2019

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Record Details

An FDA inspection of Greatbatch Medical S. De R.L. De C.V. in Tijuana, Mexico, revealed a significant issue with their quality system. The firm failed to adequately establish procedures for the acceptance of incoming raw materials and components for their Senza Spinal Cord Stimulation System, specifically the Nevro IPG 2K. This indicates a lapse in ensuring product specifications are met before manufacturing.

Company: Greatbatch Medical S. De R.L. De C.V.
Inspection Date: August 15, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Tania E. Vizcaino

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ID · 3d6fed30-048c-4d76-97cd-9833be91c5b0