Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.November 21, 2024

FDA 483 - Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. - November 21, 2024

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Record Details

Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. in Aprilia, Italy, was inspected by the FDA from November 18-21, 2024. The inspection revealed a significant issue regarding the timely submission of annual reports for approved drug products. This indicates a lapse in regulatory compliance concerning post-market reporting requirements.

Company: Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Inspection Date: November 21, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Jeanne J. Thai (investigator)

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ID · d7059bea-8b7a-4262-a5ff-c10f6c5dafac