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

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.