FDA Inspection 556640 — IDEV Technologies, Inc.
The FDA completed an inspection of IDEV Technologies, Inc. on Jan 21, 2009 in Webster, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 21, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Webster, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2556 | 21 CFR 820.30(c) | Incomplete, ambiguous, conflicting design requirements |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3675 | 21 CFR 820.30(f) | Design verification - unresolved discrepancies |