# FDA 483 - Martech Medical Products, Mexico - September 28, 2017

Source: https://www.globalkeysolutions.net/records/483/martech-medical-products-mexico/a875df3d-dc5b-4566-9d3f-8222beb98a1f

> FDA 483 for Martech Medical Products, Mexico on September 28, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Martech Medical Products, Mexico
- Inspection Date: 2017-09-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Martech Medical Products in Mexicali, Mexico, revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions and sterilization process control. These issues led to the release of unsterile product and a subsequent recall, indicating serious risks to product quality and patient safety.

## Related Officers

- [Quality Systems Engineer at Boston Scientific](https://www.globalkeysolutions.net/people/kyle-j-mccracken/5085937f-3231-4639-8d84-0e528a954824)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

Company: https://www.globalkeysolutions.net/companies/martech-medical-products-mexico/76e77ddd-b31a-4fb9-b1ff-37e95fcff0a3

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