FDA Inspection 1094102 — Belimed D.O.O.
The FDA completed an inspection of Belimed D.O.O. on June 21, 2019 in Grosuplje. 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
- June 21, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Grosuplje (Slovenia)
Citations
| ID | CFR | Description |
|---|---|---|
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |