# FDA 483 - InvaGen Pharmaceuticals, Inc. - July 17, 2026

Source: https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/e2345939-67d8-4074-9a86-ab1550cc29d5

> FDA 483 for InvaGen Pharmaceuticals, Inc. on July 17, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: InvaGen Pharmaceuticals, Inc.
- Inspection Date: 2026-07-17
- Product Type: drugs
- Office Name: FDA District Office — Jamaica, New York
- Summary: DoveGen Pharmaceuticals, Inc. in Central Islip, NY, a manufacturer and packager, was cited for failing to establish sufficient systems and processes to comply with the Drug Supply Chain Security Act (DSCSA). The inspection revealed deficiencies in their procedures for identifying and investigating suspect products, responding to illegitimate product notifications, and notifying relevant parties. This indicates a significant gap in their drug supply chain security protocols.

## Related Documents

- [483 - 2018-12-19](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/2af71d23-d9ae-4f56-9f18-57832ee945e4)
- [483 - 2023-09-19](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/eca1c26b-b995-4b88-b035-e4b5f5448a65)
- [EIR - 2018-12-19](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/4599863e-7506-4671-bafa-fe91fe8b268c)
- [483 - 2023-09-19](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/bb688776-6556-492a-bab9-c6c9545a7177)
- [EIR - 2017-05-26](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/d35bff75-1d50-4a21-ad9e-c266c4211edb)

## Related Officers

- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)
- [Luxuly Abraham](https://www.keypedia.com/people/luxuly-abraham/d33e3164-ec89-488b-bab9-a9ec30544970)

Company: https://www.keypedia.com/companies/invagen-pharmaceuticals-inc/4edf588a-64bd-4eba-9755-cbf216710d03

Office: https://www.keypedia.com/offices/fda-district-office-jamaica-new-york/2378afe9-4b40-47f5-9bd2-7db3ff83d898
