# FDA 483 - Marina Elena Cazzaniga, MD - November 21, 2025

Source: https://www.globalkeysolutions.net/records/483/marina-elena-cazzaniga-md/b1ce4ccc-0b64-40a3-94c4-d31931b49f50

> FDA 483 for Marina Elena Cazzaniga, MD on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marina Elena Cazzaniga, MD
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Marina Elena Cazzaniga, MD, a clinical investigator in Monza, Italy, was cited for significant deficiencies in conducting clinical studies. The inspection revealed multiple discrepancies between source documents and electronic Case Report Forms (eCRF) for investigational drug subjects, indicating poor data integrity. Additionally, the firm failed to obtain proper informed consent for the collection of biological samples from two subjects.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)

Company: https://www.globalkeysolutions.net/companies/marina-elena-cazzaniga-md/91a2ef10-426f-45ca-8299-1e3287916986

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