FDA Inspection
Laser Engineering, Inc.Laser Engineering, Inc. – FDA Inspection, Apr 17, 2013
Record Details
This FDA Inspection record concerns Laser Engineering, Inc., with an inspection on April 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Laser Engineering, Inc.
- Inspection Date
- April 17, 2013
- Product Type
- Devices
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ID · 9c96e4d0-de2e-4bef-97f7-f7308d6b2abf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 829344
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
19- 21 CFR 1040.10(h)(2)(ii)Reproductions of warnings
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 1002.13Lack of required elements
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 1040.10(f)(1)Protective housing
- 21 CFR 1040.10(f)(2)(i)Safety interlock not provided
- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 1040.10(g)(7)(v)DIPH label wording - Class IV
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
Showing 10 of 19 citations.
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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 |
| October 17, 2008 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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 542563 - 2008-10-17
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