FDA Inspection 1100977 — Biomerieux Inc
The FDA completed an inspection of Biomerieux Inc on Aug 20, 2019 in Hazelwood, MO. 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
- Aug 20, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hazelwood, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |