FDA Inspection 932632 — Intrinsic Therapeutics, Inc.
The FDA completed an inspection of Intrinsic Therapeutics, Inc. on Jun 16, 2015 in Woburn, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3218 | 21 CFR 820.70(c) | Environmental control system-documentation/review inspection |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3670 | 21 CFR 820.20(c) | Management review participants |
| 3837 | 21 CFR 820.25(b) | Training records |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |