FDA Inspection 1055007 — Organogenesis, Inc.
The FDA completed an inspection of Organogenesis, Inc. on June 8, 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Canton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |