FDA Inspection 1150552 — Exercore, LLC
The FDA completed an inspection of Exercore, LLC on Sep 2, 2021 in Shakopee, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 2, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shakopee, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |