FDA Inspection 590674 — AssureImmune, LLC
The FDA completed an inspection of AssureImmune, LLC on June 16, 2009 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12312 | 21 CFR 1271.160(b)(2) | Procedures for complaints and other information |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12490 | 21 CFR 1271.85(b)(1) | Cell-associated CD |