# FDA 483 - DONOVIVO, LLC - April 29, 2026

Source: https://www.keypedia.com/records/483/donovivo-llc/e6c519e8-07ad-41a8-b220-5d1ddd520125

> FDA 483 for DONOVIVO, LLC on April 29, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DONOVIVO, LLC
- Inspection Date: 2026-04-29
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: DONOVIVO, LLC in Novi, MI, was inspected by the FDA, resulting in two observations. The firm failed to properly label collected whole blood units not intended for transfusion and did not prepare or maintain written investigation reports for documented blood donor adverse events. These issues indicate deficiencies in labeling and quality system procedures for handling adverse reactions.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-j-gretkierewicz/d2b43230-5324-44e0-9cd0-7e40464bf5b0)

Company: https://www.keypedia.com/companies/donovivo-llc/82f87458-8ea2-4384-b61e-f35896de86c9

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03