FDA Inspection 1099499 — BioDlogics LLC
The FDA completed an inspection of BioDlogics LLC on August 8, 2019 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
- August 8, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Cordova, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12401 | 21 CFR 1271.230(b) | Reduced risk representation |
| 12459 | 21 CFR 1271.320(b) | Sufficient information to draw conclusions |
| 12469 | 21 CFR 1271.350(a)(1) | Adverse reaction reporting to FDA |