FDA Inspection 722813 — Myotronics-Noromed Inc
The FDA completed an inspection of Myotronics-Noromed Inc on May 12, 2011 in Kent, WA. 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
- May 12, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kent, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |