FDA Inspection 795980 — Solace Therapeutics, Inc.
The FDA completed an inspection of Solace Therapeutics, Inc. on August 24, 2012 in Framingham, 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Framingham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |