FDA Inspection
Tekna Manufacturing, LLCTekna Manufacturing, LLC – FDA Inspection, Jul 22, 2013
Record Details
This FDA Inspection record concerns Tekna Manufacturing, LLC, with an inspection on July 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tekna Manufacturing, LLC
- Inspection Date
- July 22, 2013
- Product Type
- Devices
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ID · b2a5712f-4057-4eb9-a6e4-955802d48960
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841403
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.198(a)Complaints
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Tekna Manufacturing, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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