FDA Inspection
Champion Mfg IncChampion Mfg Inc – FDA Inspection, Nov 14, 2011
Record Details
This FDA Inspection record concerns Champion Mfg Inc, with an inspection on November 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Champion Mfg Inc
- Inspection Date
- November 14, 2011
- Product Type
- Devices
View Company Profile
ID · d213c2b8-21ac-453b-82ce-dbf2cd3ee425
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Champion Mfg Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2025 | VAI | Florida District Office | Compliance: Medical Devices |
| July 12, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 27, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 21, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 8, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Champion Mfg Inc
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.