FDA Inspection
Galloway Technologies, LLCGalloway Technologies, LLC – FDA Inspection, May 17, 2012
Record Details
This FDA Inspection record concerns Galloway Technologies, LLC, with an inspection on May 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Galloway Technologies, LLC
- Inspection Date
- May 17, 2012
- Product Type
- Devices
View Company Profile
ID · bf8b6082-bff1-467c-907a-36e4b8ef6921
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 782021
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.50(b)Supplier notification of changes
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Galloway Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Galloway Technologies, LLC
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.