FDA Inspection 1293904 — Bello Bio LLC
The FDA completed an inspection of Bello Bio LLC on Dec 16, 2025 in Scottsdale, AZ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 16 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 16, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |