# FDA 483 - InvaGen Pharmaceuticals, Inc. - May 25, 2018

Source: https://www.globalkeysolutions.net/records/483/invagen-pharmaceuticals-inc/a6dbd9aa-b64c-4e7b-a80b-5e4415cf4427

> FDA 483 for InvaGen Pharmaceuticals, Inc. on May 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InvaGen Pharmaceuticals, Inc.
- Inspection Date: 2018-05-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Invagen Pharmaceuticals, Inc. in Hauppauge, NY, was inspected and cited for significant deficiencies in quality control and data management. The inspection revealed failures in timely field alert reporting for out-of-specification results and product mix-ups, inadequate investigation of discrepancies and complaints, and non-adherence to stability testing programs. Additionally, the firm experienced a ransomware attack that led to the permanent loss of critical electronic laboratory data due to a lack of secure backups.

## Related Documents

- [EIR - 2015-03-13](https://www.globalkeysolutions.net/records/eir/invagen-pharmaceuticals-inc/701032da-342e-43e5-be08-0f4783273bd6)
- [483 - 2015-05-26](https://www.globalkeysolutions.net/records/483/invagen-pharmaceuticals-inc/9b59fb71-e2c5-4425-8b81-435bdfc881b7)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/invagen-pharmaceuticals-inc/4386aad6-6947-4ea2-92d6-9da36356a820)
- [EIR - 2019-12-06](https://www.globalkeysolutions.net/records/eir/invagen-pharmaceuticals-inc/dc2ab2c9-e4f4-4c34-ba49-691cf2a6eac6)
- [483 - 2019-12-06](https://www.globalkeysolutions.net/records/483/invagen-pharmaceuticals-inc/0d160542-dc31-422d-ae64-99643402a0c5)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

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

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