FDA Inspection 542486 — Natus Medical Inc
The FDA completed an inspection of Natus Medical Inc on Oct 15, 2008 in Mundelein, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 15, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mundelein, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3151 | 21 CFR 820.180 | Legibility |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4189 | 21 CFR 820.198(a) | General |