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

Source: https://www.keypedia.com/records/483/greatbatch-medical-s-de-rl-de-cv/3d6fed30-048c-4d76-97cd-9833be91c5b0

> FDA 483 for Greatbatch Medical  S. De R.L. De C.V. on August 15, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greatbatch Medical  S. De R.L. De C.V.
- Inspection Date: 2019-08-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Tania E. Vizcaino](https://www.keypedia.com/people/tania-e-vizcaino/a142e189-697e-4962-97a9-8d24a52d690e)

Company: https://www.keypedia.com/companies/greatbatch-medical-s-de-rl-de-cv/d99c9bd8-e056-4cb2-85b8-5c6d7df1c41c

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd