FDA Inspection
Laser Engineering, Inc.Laser Engineering, Inc. – FDA Inspection, Oct 17, 2008
Record Details
This FDA Inspection record concerns Laser Engineering, Inc., with an inspection on October 17, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Laser Engineering, Inc.
- Inspection Date
- October 17, 2008
- Product Type
- Devices
View Company Profile
ID · ce8bffa3-bc04-471d-8e92-dbf2a8be28b9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 542563
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
10- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.198(a)General
- 21 CFR 820.25(b)Training
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)(7)Identifying relevant info for management review
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.200(d)No Service reports
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 1002.13Failure to submit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Laser Engineering, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 1, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| April 4, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 17, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Laser Engineering, Inc.
- FDA Inspection 1276634 - 2025-06-26
- FDA Inspection 1071050 - 2018-08-01
- FDA Inspection 872544 - 2014-04-04
- FDA Inspection 829344 - 2013-04-17
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