FDA Inspection 1224711 — Roche Molecular Systems, Inc.
The FDA completed an inspection of Roche Molecular Systems, Inc. on December 8, 2023 in Branchburg, NJ. 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
- December 8, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Branchburg, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 9225 | 21 CFR 606.171 | Biological product deviation report |