FDA Inspection 583676 — Phoenix Medical Devices, LLC
The FDA completed an inspection of Phoenix Medical Devices, LLC on May 13, 2009 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 19 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 13, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |