FDA Inspection 1293902 — Regen Suppliers LLC
The FDA completed an inspection of Regen Suppliers LLC on Dec 16, 2025 in Scottsdale, AZ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 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 |
|---|---|---|
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |