FDA Inspection 542563 — Laser Engineering, Inc.
The FDA completed an inspection of Laser Engineering, Inc. on Oct 17, 2008 in Nashville, TN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 17, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3349 | 21 CFR 820.200(d) | No Service reports |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4169 | 21 CFR 820.100(a)(7) | Identifying relevant info for management review |
| 4189 | 21 CFR 820.198(a) | General |
| 5007 | 21 CFR 1002.13 | Failure to submit |