FDA Inspection
W & R Investments LLC d.b.a. Laser EngineeringW & R Investments LLC d.b.a. Laser Engineering – FDA Inspection, Aug 21, 2017
Record Details
This FDA Inspection record concerns W & R Investments LLC d.b.a. Laser Engineering, with an inspection on August 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 21, 2017
- Product Type
- Devices
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ID · e1160717-bd59-4ad4-8317-44a02d171451
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022865
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(g)Design validation - production units
Full citation text and observation details available on the Dashboard.
Other FDA inspections of W & R Investments LLC d.b.a. Laser Engineering
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 17, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for W & R Investments LLC d.b.a. Laser Engineering
- FDA Inspection 1181973 - 2022-10-13
- FDA Inspection 966715 - 2016-04-13
- FDA Inspection 859481 - 2013-12-17
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