FDA Inspection 1014251 — MetaGen Corp.
The FDA completed an inspection of MetaGen Corp. on June 14, 2017 in Belmont, 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
- June 14, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Belmont, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |