FDA Inspection 648317 — Klarity Medical Products LLC
The FDA completed an inspection of Klarity Medical Products LLC on February 23, 2010 in Heath, OH. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Heath, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |