FDA Inspection
Techman International LLCTechman International LLC – FDA Inspection, Jun 12, 2013
Record Details
This FDA Inspection record concerns Techman International LLC, with an inspection on June 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Techman International LLC
- Inspection Date
- June 12, 2013
- Product Type
- Devices
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ID · 2472db8d-0aae-4dfb-88a4-324bc95548b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835589
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.184DHR content
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Other FDA inspections of Techman International LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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