# FDA 483 - Navinta, LLC - June 29, 2023

Source: https://www.keypedia.com/records/483/navinta-llc/2d8fac09-1d22-43ef-972e-36ca1184987c

> FDA 483 for Navinta, LLC on June 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Navinta, LLC
- Inspection Date: 2023-06-29
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Navinta, LLC, a manufacturer in Ewing, NJ, was inspected by the FDA from June 20-29, 2023. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for supplier evaluation, design control, quality audits, and corrective and preventive actions. Furthermore, critical manufacturing and packing processes for device components were found to be inadequately validated, leading to high reject rates without documented reasons.

## Related Documents

- [483 - 2019-03-28](https://www.keypedia.com/records/483/navinta-llc/220bccf8-f824-45eb-9607-8652af691d90)

## Related Officers

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

Company: https://www.keypedia.com/companies/navinta-llc/2049d986-174a-414f-812b-0f4347426e48

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