# FDA 483 - Nexgen Pharma Inc - August 17, 2018

Source: https://www.keypedia.com/records/483/nexgen-pharma-inc/c8d8ae2d-9ece-47fa-82c1-02a5e7eecd8d

> FDA 483 for Nexgen Pharma Inc on August 17, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nexgen Pharma Inc
- Inspection Date: 2018-08-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Nexgen Pharma Inc. in Irvine, CA, was inspected and cited for significant deficiencies in its post-marketing adverse drug experience reporting system. Observations included a lack of adequate written procedures for adverse event surveillance and reporting, failure to submit complete periodic reports, and untimely submission of annual reports. Additionally, the firm did not submit all safety reports in the required electronic format.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/richard-abate/655e812f-2dd8-4566-9b21-06b21a0ec6d3)
- [investigator](https://www.keypedia.com/people/angela-shepas/743113c1-799b-44e9-9422-8049c476bfd2)

Company: https://www.keypedia.com/companies/nexgen-pharma-inc/846c3742-10b0-4d7f-a9e5-18eac938d5d9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6