FDA Inspection
AmpronixAmpronix – FDA Inspection, Jul 13, 2011
Record Details
This FDA Inspection record concerns Ampronix, with an inspection on July 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ampronix
- Inspection Date
- July 13, 2011
- Product Type
- Devices
View Company Profile
ID · 57a468f0-36fa-41c3-a7f9-909bacf8a16d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734287
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.180(b)Retention period
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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.