FDA Inspection 975170 — Medfaxx, Inc.
The FDA completed an inspection of Medfaxx, Inc. on June 13, 2016 in Wake Forest, NC. 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
- June 13, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wake Forest, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4429 | 21 CFR 803.18(d)(2) | Record retention period - distributor |
| 4431 | 21 CFR 803.18(d)(1) | Distributor's device incident records |