FDA Inspection 676486 — Oto Med Inc
The FDA completed an inspection of Oto Med Inc on August 18, 2010 in Lake Havasu City, AZ. 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
- August 18, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lake Havasu City, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |