FDA Inspection 643042 — Omnitech Systems, Inc.
The FDA completed an inspection of Omnitech Systems, Inc. on Feb 3, 2010 in Valparaiso, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 3, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Valparaiso, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |