FDA Inspection 677838 — Unomedical s.r.o.
The FDA completed an inspection of Unomedical s.r.o. on July 22, 2010 in Michalovce. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Michalovce (Slovakia)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |