FDA Inspection 579046 — Spectramed LLC
The FDA completed an inspection of Spectramed LLC on May 7, 2009 in Columbus, OH. 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
- May 7, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2601 | 21 CFR 820.30(d) | Essential design outputs |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |