FDA Inspection 769247 — Argon Medical Devices Inc.
The FDA completed an inspection of Argon Medical Devices Inc. on Jan 18, 2012 in Wheeling, IL. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 18, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wheeling, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |