FDA Inspection
Trac About IncTrac About Inc – FDA Inspection, Feb 11, 2010
Record Details
This FDA Inspection record concerns Trac About Inc, with an inspection on February 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trac About Inc
- Inspection Date
- February 11, 2010
- Product Type
- Devices
View Company Profile
ID · 7a141345-1cae-4cd3-85f2-dda15cb205ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 647643
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(d)(2)Review of data and documentation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(e)Maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trac About Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Trac About Inc
- FDA Inspection 803577 - 2012-10-18
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