FDA Inspection
ACUTE Innovations LLCACUTE Innovations LLC – FDA Inspection, Oct 21, 2011
Record Details
This FDA Inspection record concerns ACUTE Innovations LLC, with an inspection on October 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ACUTE Innovations LLC
- Inspection Date
- October 21, 2011
- Product Type
- Devices
View Company Profile
ID · f3dfe4aa-11db-474e-ad19-47446b37d245
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752065
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ACUTE Innovations LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 19, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ACUTE Innovations LLC
- FDA Inspection 954923 - 2016-01-28
- FDA Inspection 828035 - 2013-04-19
- FDA Inspection 676409 - 2010-08-19
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.