FDA Inspection 1024529 — Genesys Orthopedics Systems, LLC
The FDA completed an inspection of Genesys Orthopedics Systems, LLC on September 8, 2017 in West Lake Hills, TX. 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
- September 8, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- West Lake Hills, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |