# FDA 483 - Amerigen Pharmaceuticals Inc. - July 27, 2017

Source: https://www.keypedia.com/records/483/amerigen-pharmaceuticals-inc/0ac14809-47bb-4a47-b131-09b6e4feab39

> FDA 483 for Amerigen Pharmaceuticals Inc. on July 27, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amerigen Pharmaceuticals Inc.
- Inspection Date: 2017-07-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Amerigen Pharmaceuticals Inc. in Lyndhurst, NJ, revealed significant deficiencies in the firm's written procedures for handling post-marketing adverse drug experiences. The company lacked adequate procedures for the surveillance, evaluation, and reporting of adverse drug events to the FDA. This indicates a serious gap in their pharmacovigilance system.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/anastasia-offordile/299aed81-16f8-413e-a318-2d7f741957da)

Company: https://www.keypedia.com/companies/amerigen-pharmaceuticals-inc/249d618c-b415-40b6-b86d-53c20e6e7db8

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248