FDA Inspection 868748 — Miracles in Sight
The FDA completed an inspection of Miracles in Sight on February 26, 2014 in Winston Salem, NC. 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
- February 26, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Winston Salem, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12345 | 21 CFR 1271.190(b)(1) | Clean, sanitary, orderly manner |