FDA Inspection 1202923 — Eurofins Viracor, LLC.
The FDA completed an inspection of Eurofins Viracor, LLC. on April 19, 2023 in Lenexa, KS. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lenexa, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |