FDA Inspection 1284408 — Minaris Regenerative Medicine, LLC
The FDA completed an inspection of Minaris Regenerative Medicine, LLC on September 29, 2025 in Allendale, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Allendale, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |