# FDA 483 - Amici Pharma Inc. - November 12, 2024

Source: https://www.keypedia.com/records/483/amici-pharma-inc/55a80280-31ed-4e87-9f1f-b55eb40a65fc

> FDA 483 for Amici Pharma Inc. on November 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amici Pharma Inc.
- Inspection Date: 2024-11-12
- Product Type: drugs
- Office Name: New York District Office
- Summary: Amici Pharma Inc. in Melville, NY, a manufacturer, was inspected by the FDA. The inspection revealed a significant regulatory non-compliance regarding the timely submission of annual reports for an Abbreviated New Drug Application (ANDA). Specifically, the firm failed to submit the required annual reports for ANDA 076-561 for both 2022 and 2023.

## Related Officers

- [Omadevi Somai](https://www.keypedia.com/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)

Company: https://www.keypedia.com/companies/amici-pharma-inc/b5ee1482-048c-48ea-8f45-780c5773422c

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d