FDA Inspection 1121946 — FCM SMART CENTER GROUP
The FDA completed an inspection of FCM SMART CENTER GROUP on Feb 25, 2020 in Odessa, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 25, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Odessa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |