FDA Inspection 1079816 — Monarch Medical Technologies, LLC
The FDA completed an inspection of Monarch Medical Technologies, LLC on Feb 19, 2019 in Charlotte, NC. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |