FDA Inspection
Galloway Technologies, LLCGalloway Technologies, LLC – FDA Inspection, Mar 2, 2011
Record Details
This FDA Inspection record concerns Galloway Technologies, LLC, with an inspection on March 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Galloway Technologies, LLC
- Inspection Date
- March 2, 2011
- Product Type
- Devices
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ID · eb9137e4-5420-4bbe-bce6-017216bea947
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 712415
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
20- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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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 |
| May 17, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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