FDA Inspection
Tra & AccessoriesFDA Inspection 680484 - Tra & Accessories - September 14, 2010
Record Details
This FDA Inspection record concerns Tra & Accessories, with an inspection on September 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tra & Accessories
- Inspection Date
- September 14, 2010
- Product Type
- Devices
View Company Profile
ID · aa777db3-f78d-4a87-a436-b01cfb219263
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680484
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tra & Accessories
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tra & Accessories
- FDA Inspection 890219 - 2014-07-29
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.