FDA Inspection 1066628 — MICROLAB ELETTRONICA
The FDA completed an inspection of MICROLAB ELETTRONICA on Sep 25, 2018 in Ponte San Nicolo'. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 25, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ponte San Nicolo' (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |