FDA Inspection
W & R Investments LLC d.b.a. Laser EngineeringW & R Investments LLC d.b.a. Laser Engineering – FDA Inspection, Dec 17, 2013
Record Details
This FDA Inspection record concerns W & R Investments LLC d.b.a. Laser Engineering, with an inspection on December 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 17, 2013
- Product Type
- Devices
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ID · 2503b91b-ec95-43a6-9e1d-a2019939c25a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859481
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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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 |
| April 13, 2016 | OAI | 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 966715 - 2016-04-13
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