Amici Pharma Inc.November 12, 2024

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

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Record Details

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.

Company: Amici Pharma Inc.
Inspection Date: November 12, 2024
Product Type: Drugs
Office: New York District Office
Person: Omadevi Somai

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ID · 55a80280-31ed-4e87-9f1f-b55eb40a65fc