# FDA 483 - Bello Bio LLC - December 16, 2025

Source: https://www.keypedia.com/records/483/bello-bio-llc/eddc3f8d-9e1b-4f39-9671-c99285af2c8e

> FDA 483 for Bello Bio LLC on December 16, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bello Bio LLC
- Inspection Date: 2025-12-16
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Bello Bio LLC, a manufacturer of human umbilical cord tissue products, received a Form 483 citing numerous significant deficiencies across its operations. These include a complete absence of a quality control unit, lack of validated aseptic processes and manufacturing procedures, and failures in environmental monitoring, stability testing, and complaint handling. The firm also lacked proper donor eligibility documentation and controls over labeling and product quarantine, indicating systemic issues in quality assurance and regulatory compliance.

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
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Company: https://www.keypedia.com/companies/bello-bio-llc/5bbd8a0a-aaf8-404c-b010-8f9a8341f7fa

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face