FDA Inspection
Pare' Solutions, LLCFDA Inspection 680552 - Pare' Solutions, LLC - September 10, 2010
Record Details
This FDA Inspection record concerns Pare' Solutions, LLC, with an inspection on September 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pare' Solutions, LLC
- Inspection Date
- September 10, 2010
- Product Type
- Devices
View Company Profile
ID · 2de48e84-c555-4fed-aef7-58cf951fcad0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680552
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(f)Design verification - output does not meet input requirement
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pare' Solutions, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 6, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pare' Solutions, LLC
- FDA Inspection 950060 - 2015-10-29
- FDA Inspection 627333 - 2009-11-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.