# FDA 483 - Sannova Analytical LLC. - November 01, 2024

Source: https://www.keypedia.com/records/483/sannova-analytical-llc/e155357c-a51c-4d8a-8038-307ba8d08fd1

> FDA 483 for Sannova Analytical LLC. on November 01, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sannova Analytical LLC.
- Inspection Date: 2024-11-01
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Sannova Analytical, LLC, a biopharmaceutics analytical facility in Somerset, NJ, from October 28 to November 1, 2024, identified one observation. The observation concerned the firm's conduct of a protocol where concentrations were not reported as final in the study report, and data was retrospectively excluded. This indicates a concern regarding data integrity and reporting practices.

## Related Officers

- [Angelica M. Chica](https://www.keypedia.com/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)
- [Sarmistha Sanyal](https://www.keypedia.com/people/sarmistha-sanyal/62968fd4-75e3-4110-a66d-d3ff63460a33)

Company: https://www.keypedia.com/companies/sannova-analytical-llc/4564920c-4841-4b90-bdfe-d1e6d4853a3e

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