FDA Inspection
Monarch Molding IncMonarch Molding Inc – FDA Inspection, Mar 27, 2024
Record Details
This FDA Inspection record concerns Monarch Molding Inc, with an inspection on March 27, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dd17bded-3deb-4c95-a9c1-fb197792459c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234299
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Monarch Molding Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Monarch Molding Inc
- FDA Inspection 1006141 - 2017-03-16
- FDA Inspection 883834 - 2014-06-18
- FDA Inspection 635269 - 2009-12-16
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