FDA Inspection
Den-Mat Holdings, LLCDen-Mat Holdings, LLC – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns Den-Mat Holdings, LLC, with an inspection on April 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6d03b1f5-253b-4997-9c3d-bd1ea3163d9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012019
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
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 | |
| March 13, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 12, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 871446 - 2014-03-13
- FDA Inspection 841746 - 2013-07-12
- FDA Inspection 671868 - 2010-06-24
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