FDA Inspection 1102625 — M.D.L. S.r.l.
The FDA completed an inspection of M.D.L. S.r.l. on September 19, 2019 in Delebio. 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
- September 19, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Delebio (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |