FDA Inspection
W & R Investments LLC d.b.a. Laser EngineeringW & R Investments LLC d.b.a. Laser Engineering – FDA Inspection, Apr 13, 2016
Record Details
This FDA Inspection record concerns W & R Investments LLC d.b.a. Laser Engineering, with an inspection on April 13, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 13, 2016
- Product Type
- Devices
View Company Profile
ID · 03d40acf-d76f-4c9e-bc09-71fdee7a240b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 966715
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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 |
| August 21, 2017 | VAI | 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 1022865 - 2017-08-21
- FDA Inspection 859481 - 2013-12-17
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