FDA Inspection 1260289 — Rose BioSolutions Memphis LLC
The FDA completed an inspection of Rose BioSolutions Memphis LLC on Feb 7, 2025 in Memphis, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 7, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |