FDA Inspection 560475 — 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). 8 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 |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |