FDA Inspection 781259 — BioDlogics LLC
The FDA completed an inspection of BioDlogics LLC on April 27, 2012 in Cordova, TN. 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
- April 27, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Cordova, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |