FDA Inspection 648317 — Klarity Medical Products LLC
The FDA completed an inspection of Klarity Medical Products LLC on Feb 23, 2010 in Heath, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 23, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |