FDA Inspection 1119945 — Concert Medical, LLC
The FDA completed an inspection of Concert Medical, LLC on March 5, 2020 in Norwell, 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Norwell, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |