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

Source: https://www.keypedia.com/records/483/istituto-biochimico-italiano-giovanni-lorenzini-spa/d7059bea-8b7a-4262-a5ff-c10f6c5dafac

> FDA 483 for Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. on November 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
- Inspection Date: 2024-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2024-11-21](https://www.keypedia.com/records/483/istituto-biochimico-italiano-giovanni-lorenzini-spa/41f5e789-42a2-4236-b1fa-78df03e257ba)

## Related Officers

- [investigator](https://www.keypedia.com/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.keypedia.com/companies/istituto-biochimico-italiano-giovanni-lorenzini-spa/15ae51d8-a4ba-42a6-9100-2d04641f2514

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8