# FDA 483 - Nitinol Devices and Components Costa Rica, S.R.L. - February 06, 2020

Source: https://www.keypedia.com/records/483/nitinol-devices-and-components-costa-rica-srl/08b52f7a-7f05-4a4f-8c88-5972c0365155

> FDA 483 for Nitinol Devices and Components Costa Rica, S.R.L. on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nitinol Devices and Components Costa Rica, S.R.L.
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Mitchel Devices and Components Costa Rica, S.R.L., a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, insufficient equipment inspection and maintenance, and untimely processing of customer complaints. These issues indicate systemic problems in maintaining a compliant quality management system.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/nitinol-devices-and-components-costa-rica-srl/314bc48b-6c25-44f7-b49b-5ecadef33100

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