FDA Inspection 1119092 — LC Medical Concepts, Inc
The FDA completed an inspection of LC Medical Concepts, Inc on February 25, 2020 in Rochester, NY. 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
- February 25, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |