# FDA 483 - InvaGen Pharmaceuticals, Inc. - December 06, 2019

Source: https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/0d160542-dc31-422d-ae64-99643402a0c5

> FDA 483 for InvaGen Pharmaceuticals, Inc. on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InvaGen Pharmaceuticals, Inc.
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of InvaGen Pharmaceuticals, Inc. in Hauppauge, NY, revealed significant deficiencies in drug manufacturing practices. Observations included inadequate review of analytical data prior to product release, failure to follow established in-process controls, and insufficient documentation of critical manufacturing steps. These issues indicate a lack of robust quality control and data integrity within the firm's operations.

## Related Documents

- [EIR - 2015-03-13](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/701032da-342e-43e5-be08-0f4783273bd6)
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- [EIR - 2019-12-06](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/dc2ab2c9-e4f4-4c34-ba49-691cf2a6eac6)

## Related Officers

- [Ganesh Joshi](https://www.keypedia.com/people/ganesh-joshi/404dea61-8ccf-49f3-a8a5-990210f48524)
- [investigator](https://www.keypedia.com/people/jose-o-hernandez/960bffbe-1b8e-41bc-b203-aee88d7d8dac)

Company: https://www.keypedia.com/companies/invagen-pharmaceuticals-inc/8841516b-25bb-463f-9666-11b69458c306

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