FDA Inspection
Theken Companies LLCTheken Companies LLC – FDA Inspection, Jul 2, 2010
Record Details
This FDA Inspection record concerns Theken Companies LLC, with an inspection on July 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Theken Companies LLC
- Inspection Date
- July 2, 2010
- Product Type
- Devices
View Company Profile
ID · acb72e96-22f0-4545-b857-af61862dcaeb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669644
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Theken Companies LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Theken Companies LLC
- FDA Inspection 1074413 - 2018-12-13
- FDA Inspection 748188 - 2011-10-17
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