# FDA 483 - Evergreen Theragnostics, Inc. - February 23, 2023

Source: https://www.keypedia.com/records/483/evergreen-theragnostics-inc/cdc7c254-d490-4374-bd53-7d07152a1dec

> FDA 483 for Evergreen Theragnostics, Inc. on February 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evergreen Theragnostics, Inc.
- Inspection Date: 2023-02-23
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Evergreen Theragnostics, Inc. in Springfield, NJ, received two observations during an FDA inspection of its testing laboratory for PET drug products. The firm failed to document investigations for out-of-specification results and did not consistently follow written procedures for conducting tests. These issues indicate deficiencies in quality control and laboratory practices related to drug product testing.

## Related Officers

- [Annet R. Rajan](https://www.keypedia.com/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)
- [Director of Clinical Training](https://www.keypedia.com/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

Company: https://www.keypedia.com/companies/evergreen-theragnostics-inc/eebe45ef-57f4-4d3c-b039-b3d2eb96aa99

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