FDA Inspection 565407 — Evenflo Co Inc
The FDA completed an inspection of Evenflo Co Inc on Feb 2, 2009 in Miamisburg, OH. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 17 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Miamisburg, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3300 | 21 CFR 820.100(a)(1) | Statistical methodology |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4168 | 21 CFR 820.100(a)(7) | Management review of CAPA |
| 4189 | 21 CFR 820.198(a) | General |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 7270 | 21 CFR 56.103(a) | IRB review requirement |