FDA Inspection 1119024 — MARVAO MEDICAL DEVICES LTD.
The FDA completed an inspection of MARVAO MEDICAL DEVICES LTD. on January 29, 2020 in Galway. 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
- January 29, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Galway (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |