# FDA 483 - InvaGen Pharmaceuticals, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/4386aad6-6947-4ea2-92d6-9da36356a820

> FDA 483 for InvaGen Pharmaceuticals, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InvaGen Pharmaceuticals, Inc.
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Invagen Pharmaceuticals, Inc. in Hauppauge, NY, a drug manufacturer, was cited for three observations during an FDA inspection in March 2017. The inspection revealed significant issues with data integrity, including failures in maintaining backup files, inadequate computer system controls allowing unauthorized data deletion, and insufficient record retention practices for drug product control and labeling. These findings indicate a lack of robust controls over electronic data and physical records, which are critical for ensuring product quality and regulatory compliance.

## Related Documents

- [EIR - 2015-03-13](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/701032da-342e-43e5-be08-0f4783273bd6)
- [483 - 2015-05-26](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/9b59fb71-e2c5-4425-8b81-435bdfc881b7)
- [483 - 2018-05-25](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/a6dbd9aa-b64c-4e7b-a80b-5e4415cf4427)
- [EIR - 2019-12-06](https://www.keypedia.com/records/eir/invagen-pharmaceuticals-inc/dc2ab2c9-e4f4-4c34-ba49-691cf2a6eac6)
- [483 - 2019-12-06](https://www.keypedia.com/records/483/invagen-pharmaceuticals-inc/0d160542-dc31-422d-ae64-99643402a0c5)

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

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