FDA Inspection 805089 — Linet Spol. S.r.o.
The FDA completed an inspection of Linet Spol. S.r.o. on November 1, 2012 in Zelevcice Slany. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 1, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zelevcice Slany (Czech Republic)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |