FDA Inspection
AcuLux, Inc.AcuLux, Inc. – FDA Inspection, Sep 4, 2015
Record Details
This FDA Inspection record concerns AcuLux, Inc., with an inspection on September 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AcuLux, Inc.
- Inspection Date
- September 4, 2015
- Product Type
- Devices
View Company Profile
ID · 7b33c1a1-28d1-4658-900f-bc780d144e04
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940918
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AcuLux, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 30, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 25, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for AcuLux, Inc.
- FDA Inspection 1099382 - 2019-08-08
- FDA Inspection 783891 - 2012-05-30
- FDA Inspection 598305 - 2009-02-25
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