FDA Inspection 1107159 — Bio-Rad Laboratories, Inc.
The FDA completed an inspection of Bio-Rad Laboratories, Inc. on October 21, 2019 in Woodinville, WA. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 21, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Woodinville, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |