FDA Inspection
Talladium IncTalladium Inc – FDA Inspection, Aug 18, 2015
Record Details
This FDA Inspection record concerns Talladium Inc, with an inspection on August 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Talladium Inc
- Inspection Date
- August 18, 2015
- Product Type
- Devices
View Company Profile
ID · 27d77397-62f4-49a3-bb32-e0587f93cd1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938671
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Talladium Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Talladium Inc
- FDA Inspection 766724 - 2012-02-09
- FDA Inspection 631242 - 2009-12-11
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