FDA Inspection
Tekna Manufacturing, LLCTekna Manufacturing, LLC – FDA Inspection, Feb 28, 2017
Record Details
This FDA Inspection record concerns Tekna Manufacturing, LLC, with an inspection on February 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9b704082-c347-4572-9069-cd2aa57cce59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006295
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Tekna Manufacturing, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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