# FDA 483 - Navinta, LLC - March 28, 2019

Source: https://www.keypedia.com/records/483/navinta-llc/220bccf8-f824-45eb-9607-8652af691d90

> FDA 483 for Navinta, LLC on March 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Navinta, LLC
- Inspection Date: 2019-03-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Navinta, LLC's corporate headquarters in Ewing, NJ, revealed a significant documentation deficiency in their postmarketing safety reporting. The firm repeatedly failed to include copies of published scientific articles when submitting 15-day Alert reports based on scientific literature. This indicates a lapse in regulatory submission completeness.

## Related Documents

- [483 - 2023-06-29](https://www.keypedia.com/records/483/navinta-llc/2d8fac09-1d22-43ef-972e-36ca1184987c)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Mihaela Jason](https://www.keypedia.com/people/mihaela-jason/7884dda5-8301-42ac-b711-e4a0c986dc68)

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