FDA Inspection 1226348 — Greiner Bio-One GmbH
The FDA completed an inspection of Greiner Bio-One GmbH on Dec 21, 2023 in Kremsmunster. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 21, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kremsmunster (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |