# FDA 483 - Enterix, Inc. - March 10, 2023

Source: https://www.globalkeysolutions.net/records/483/enterix-inc/924a0a47-3585-4e17-85e9-16a99a1d33b1

> FDA 483 for Enterix, Inc. on March 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enterix, Inc.
- Inspection Date: 2023-03-10
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Enterix, Inc. in Edison, NJ, was inspected regarding its manufacturing of InSure ONE fecal immunochemical test kits. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for corrective and preventive actions, control of nonconforming products, equipment calibration, and employee training. These issues indicate a lack of robust quality management practices.

## Related Officers

- [Frank J. Marciniak](https://www.globalkeysolutions.net/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.globalkeysolutions.net/companies/enterix-inc/f801ccab-bedf-4ec7-ab7e-57d65fed2a66

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