FDA Inspection
CURALLUX LLCCURALLUX LLC – FDA Inspection, Apr 17, 2019
Record Details
This FDA Inspection record concerns CURALLUX LLC, with an inspection on April 17, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c17b0396-9edb-4fa6-977c-0d9468ebc04a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1086640
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.11Failure to submit
- 21 CFR 1010.2(a)Lack of certification of conformance
- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 1040.10(h)(2)(i)Reproduction of affixed information
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Other FDA inspections of CURALLUX LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2019 | Not classified | Florida District Office | |
| August 9, 2017 | Not classified | Florida District Office | |
| May 10, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 7, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 16, 2013 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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