FDA Inspection 1099854 — SCHOTT CR, S.R.O.
The FDA completed an inspection of SCHOTT CR, S.R.O. on August 16, 2019 in Krasno Nad Becvou. 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
- August 16, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Krasno Nad Becvou (Czech Republic)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |