FDA Inspection
Medivators IncMedivators Inc – FDA Inspection, Dec 17, 2012
Record Details
This FDA Inspection record concerns Medivators Inc, with an inspection on December 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medivators Inc
- Inspection Date
- December 17, 2012
- Product Type
- Devices
View Company Profile
ID · fac36efd-4880-4959-adc1-a5c7266719cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809682
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medivators Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 13, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medivators Inc
- FDA Inspection 1021886 - 2017-03-31
- FDA Inspection 655718 - 2010-04-13
- FDA Inspection 566785 - 2009-03-13
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.