FDA Inspection 1084059 — Unysen Health, Inc
The FDA completed an inspection of Unysen Health, Inc on March 27, 2019 in Mansfield, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mansfield, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |