FDA Inspection
Nuvolase Inc.Nuvolase Inc. – FDA Inspection, Sep 20, 2013
Record Details
This FDA Inspection record concerns Nuvolase Inc., with an inspection on September 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nuvolase Inc.
- Inspection Date
- September 20, 2013
- Product Type
- Devices
View Company Profile
ID · e39ed00f-02a6-41a1-8ecd-d8b518030c6e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 850450
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nuvolase Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2018 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 13, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 3, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Nuvolase Inc.
- FDA Inspection 1052985 - 2018-05-23
- FDA Inspection 917181 - 2015-03-13
- FDA Inspection 652943 - 2010-05-03
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