FDA Inspection 592441 — Terumo BCT, Inc.
The FDA completed an inspection of Terumo BCT, Inc. on June 23, 2009 in Lakewood, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lakewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |