FDA Inspection 1148958 — RxFunction Inc.
The FDA completed an inspection of RxFunction Inc. on Aug 6, 2021 in Eden Prairie, MN. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 6, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eden Prairie, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4213 | 21 CFR 806.20(b)(5) | Records of communications |