# FDA 483 - InvaGen Pharmaceuticals, Inc. - September 19, 2023

Source: https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/eca1c26b-b995-4b88-b035-e4b5f5448a65

> FDA 483 for InvaGen Pharmaceuticals, Inc. on September 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InvaGen Pharmaceuticals, Inc.
- Inspection Date: 2023-09-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Invagen Pharmaceuticals, Inc. in Central Islip, NY, a drug manufacturer, was cited for five observations during an FDA inspection. The findings indicate significant deficiencies in quality control unit oversight, including unreviewed GMP documents, lack of bulk hold time studies for in-process materials, inadequate testing of labeling and packaging materials, and insufficient equipment cleaning. Additionally, the firm's change control procedures lacked due dates, resulting in numerous open change controls.

## Related Documents

- [EIR - 2017-05-26](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/d35bff75-1d50-4a21-ad9e-c266c4211edb)
- [EIR - 2018-12-19](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/4599863e-7506-4671-bafa-fe91fe8b268c)
- [483 - 2018-12-19](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/2af71d23-d9ae-4f56-9f18-57832ee945e4)

## Related Officers

- [Anatal H Barlow, Investigator](https://www.keypedia.com/people/anatal-h-barlow-investigator/73dfbe40-04ca-4c87-8d68-82d08f2476cf)
- [Karishma G Gopaul, Investigator](https://www.keypedia.com/people/karishma-g-gopaul-investigator/e6e0db30-4298-489a-836d-763451432f6f)
- [Bijoy Panicker, Investigator](https://www.keypedia.com/people/bijoy-panicker-investigator/f4f6d98e-8cac-4c4b-a686-3dfbee6af7d4)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961