FDA Inspection 824487 — CorneaGen - Boston
The FDA completed an inspection of CorneaGen - Boston on March 28, 2013 in Waltham, MA. 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
- March 28, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |