FDA Inspection 831748 — MicroPort CRM S.r.l.
The FDA completed an inspection of MicroPort CRM S.r.l. on March 28, 2013 in Saluggia, VC. 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) (VAI)
- End Date
- March 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saluggia, VC (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |