# FDA 483 - BioRamo, LLC - January 30, 2025

Source: https://www.globalkeysolutions.net/records/483/bioramo-llc/a9960e98-5176-4059-a697-0017ded171da

> FDA 483 for BioRamo, LLC on January 30, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BioRamo, LLC
- Inspection Date: 2025-01-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of BioRamo, LLC, a drug manufacturer in Ft Lauderdale, FL, revealed significant deficiencies in its quality control unit and material handling systems. The firm failed to adequately document investigations, ensure proper product release, and maintain effective inventory control, leading to potential contamination and mix-ups. These issues indicate a lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2025-01-30](https://www.globalkeysolutions.net/records/483/bioramo-llc/94b7004c-d0b0-4243-825e-40c0c20aca30)

## Related Officers

- [Suzanne N. Vallez](https://www.globalkeysolutions.net/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)

Company: https://www.globalkeysolutions.net/companies/bioramo-llc/c32084c1-7762-45e7-aff6-b09ea6dfdf17

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6