# FDA 483 - Medin Technologies, Inc. - February 16, 2022

Source: https://www.keypedia.com/records/483/medin-technologies-inc/1649bfe4-81d6-4b78-b35c-a47a4e944ee4

> FDA 483 for Medin Technologies, Inc. on February 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medin Technologies, Inc.
- Inspection Date: 2022-02-16
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Medin Technologies, Inc. in Totowa, NJ, a medical device manufacturer, was inspected by the FDA from December 2021 to February 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for corrective and preventive actions, complaint handling, internal audits, management reviews, supplier management, training, and document control. These findings indicate a systemic failure to maintain an effective quality system.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)
- [Melissa Zuppe](https://www.keypedia.com/people/melissa-zuppe/e34e3943-0e3c-4a24-983d-6ac8aa2cc906)

Company: https://www.keypedia.com/companies/medin-technologies-inc/bd337303-96dd-43e9-9b9c-77623f6693e5

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248