FDA Inspection 606323 — Transoma Medical
The FDA completed an inspection of Transoma Medical on Aug 28, 2009 in Saint Paul, MN. 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 28, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |