FDA Inspection
NOVO HEALTH SERVICES LLCNOVO HEALTH SERVICES LLC – FDA Inspection, May 13, 2011
Record Details
This FDA Inspection record concerns NOVO HEALTH SERVICES LLC, with an inspection on May 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- NOVO HEALTH SERVICES LLC
- Inspection Date
- May 13, 2011
- Product Type
- Devices
View Company Profile
ID · 2f1fce36-f2ed-4e0e-b234-89189304afb5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 724570
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NOVO HEALTH SERVICES LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 7, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for NOVO HEALTH SERVICES LLC
- FDA Inspection 939611 - 2015-08-26
- FDA Inspection 771243 - 2012-03-07
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.