FDA Inspection
Nuvolase Inc.Nuvolase Inc. – FDA Inspection, May 23, 2018
Record Details
This FDA Inspection record concerns Nuvolase Inc., with an inspection on May 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 701507da-e88e-494d-8e87-f843dea4599c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052985
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 1002.20(a)Failure to report
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Nuvolase Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 20, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 3, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Nuvolase Inc.
- FDA Inspection 917181 - 2015-03-13
- FDA Inspection 850450 - 2013-09-20
- FDA Inspection 652943 - 2010-05-03
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