FDA Inspection 879597 — Organogenesis, Inc.
The FDA completed an inspection of Organogenesis, Inc. on June 13, 2014 in Canton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Canton, MA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |