FDA Inspection 1009934 — Oto Med Inc
The FDA completed an inspection of Oto Med Inc on April 25, 2017 in Lake Havasu City, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 25, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lake Havasu City, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |