FDA Inspection
OmniLife ScienceOmniLife Science – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns OmniLife Science, with an inspection on December 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OmniLife Science
- Inspection Date
- December 6, 2012
- Product Type
- Devices
View Company Profile
ID · 11c66961-2553-46b3-819c-390794de3f8a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810557
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OmniLife Science
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 3, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OmniLife Science
- FDA Inspection 1166323 - 2022-04-04
- FDA Inspection 1025556 - 2017-09-13
- FDA Inspection 713580 - 2011-02-03
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.