FDA Inspection
Den-Mat Holdings, LLCDen-Mat Holdings, LLC – FDA Inspection, Dec 7, 2023
Record Details
This FDA Inspection record concerns Den-Mat Holdings, LLC, with an inspection on December 7, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f7aede10-8edc-4bfe-8fd7-fa2616ed506f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225985
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Den-Mat Holdings, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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 1051786 - 2018-01-22
- FDA Inspection 1012019 - 2017-04-28
- FDA Inspection 871446 - 2014-03-13
- FDA Inspection 841746 - 2013-07-12
- FDA Inspection 671868 - 2010-06-24
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