483
Greatbatch Medical S. De R.L. De C.V.Greatbatch Medical S. De R.L. De C.V. – FDA 483, Aug 15, 2019
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.
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ID · 3d6fed30-048c-4d76-97cd-9833be91c5b0
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