FDA Inspection
Trademark Medical LLCTrademark Medical LLC – FDA Inspection, Oct 28, 2011
Record Details
This FDA Inspection record concerns Trademark Medical LLC, with an inspection on October 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trademark Medical LLC
- Inspection Date
- October 28, 2011
- Product Type
- Devices
View Company Profile
ID · 9967ebe2-895b-4588-86ca-5ce20917f292
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 751626
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trademark Medical LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 14, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 19, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 11, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Trademark Medical LLC
- FDA Inspection 1193347 - 2022-12-14
- FDA Inspection 958270 - 2016-01-14
- FDA Inspection 870104 - 2014-03-19
- FDA Inspection 635456 - 2009-12-11
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