# FDA 483 - InvaGen Pharmaceuticals, Inc. - December 19, 2018

Source: https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/2af71d23-d9ae-4f56-9f18-57832ee945e4

> FDA 483 for InvaGen Pharmaceuticals, Inc. on December 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InvaGen Pharmaceuticals, Inc.
- Inspection Date: 2018-12-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: InvaGen Pharmaceuticals, Inc. in Central Islip, NY, was inspected by the FDA from December 10-19, 2018, resulting in a Form 483 with three observations. The inspection revealed significant issues including the failure to quarantine incoming active pharmaceutical ingredients, inadequate statistical procedures for in-process sampling, and deficiencies in the routine calibration program for critical equipment. These observations indicate a need for improved quality control and manufacturing practices at the facility.

## 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 - 2023-09-19](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/eca1c26b-b995-4b88-b035-e4b5f5448a65)

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-o-hernandez/960bffbe-1b8e-41bc-b203-aee88d7d8dac)

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