UNOMEDICAL S.R.O. — FDA Facility Profile
UNOMEDICAL S.R.O. is an FDA-registered facility (FEI 3005778470) located in MICHALOVCE Kosicky, SK. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Oct 26, 2018: No Action Indicated (NAI)
- Inspections on record
- 4 (1 OAI, 1 VAI, 2 NAI)
- Last OAI inspection
- Feb 6, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Jun 24, 2014
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 26, 2018 | No Action Indicated (NAI) | Quality audits - Lack of or inadequate procedures (21 CFR 820.22) |
| Jan 29, 2015 | No Action Indicated (NAI) | Environmental control Lack of or inadequate procedures (21 CFR 820.70(c)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Feb 6, 2014 | Official Action Indicated (OAI) | No citations listed |
| Jul 22, 2010 | Voluntary Action Indicated (VAI) | Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Processing MDRs {see also 803, 804} (21 CFR 820.198(a)(3)) CAPA verification/validation of corrective/preventive action (21 CFR 820.100(a)(4)) |
Facility details
- Company
- Unomedical S.R.O.
- Location
- MICHALOVCE Kosicky (SK)
- Source
- device