FDA Inspection
Den-Mat Holdings, LLCDen-Mat Holdings, LLC – FDA Inspection, Jul 12, 2013
Record Details
This FDA Inspection record concerns Den-Mat Holdings, LLC, with an inspection on July 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Den-Mat Holdings, LLC
- Inspection Date
- July 12, 2013
- Product Type
- Devices
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ID · fdc880bb-d36a-4409-a168-aaee7d5b1774
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841746
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(d)Evaluation, timeliness, identification
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Other FDA inspections of Den-Mat Holdings, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2018 | Not classified | Los Angeles District Office | |
| April 28, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Den-Mat Holdings, LLC
- FDA Inspection 1225985 - 2023-12-07
- FDA Inspection 1051786 - 2018-01-22
- FDA Inspection 1012019 - 2017-04-28
- FDA Inspection 871446 - 2014-03-13
- FDA Inspection 671868 - 2010-06-24
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