FDA Inspection 1050416 — Organogenesis, Inc.
The FDA completed an inspection of Organogenesis, Inc. on April 26, 2018 in Canton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Canton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |