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

Source: https://www.globalkeysolutions.net/records/483/bioramo-llc/94b7004c-d0b0-4243-825e-40c0c20aca30

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

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## Details

- Record Type: 483
- Company Name: BioRamo, LLC
- Inspection Date: 2025-01-30
- Product Type: drugs
- Office Name: Florida District Office
- Summary: BioRamo, LLC, a drug manufacturer in Ft Lauderdale, FL, was inspected by the FDA and cited for significant deficiencies. The firm's quality control unit failed to follow written procedures, specifically regarding inadequate investigations and lack of documented final product release. Additionally, the inspection revealed failures in handling and storing materials, leading to potential contamination risks due to poor inventory tracking and insufficient storage procedures.

## Related Documents

- [483 - 2025-01-30](https://www.globalkeysolutions.net/records/483/bioramo-llc/a9960e98-5176-4059-a697-0017ded171da)

## 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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9