FDA Inspection 802580 — The Judge Rotenberg Educational Center, Inc.
The FDA completed an inspection of The Judge Rotenberg Educational Center, Inc. on October 17, 2012 in Canton, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 17, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Canton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |