FDA Inspection 620055 — Miracles In Sight Lone Star Division
The FDA completed an inspection of Miracles In Sight Lone Star Division on Oct 7, 2009 in Manor, TX. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 7, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Manor, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |