FDA Inspection 643524 — Transonic Systems Inc
The FDA completed an inspection of Transonic Systems Inc on January 26, 2010 in Ithaca, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ithaca, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |