FDA Inspection
Monarch Molding IncMonarch Molding Inc – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns Monarch Molding Inc, with an inspection on March 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d30f52cb-33c7-472d-a44d-80328d047ca6
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1006141
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Monarch Molding Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2024 | VAI | Center for Devices and Radiological Health | Compliance: 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 1234299 - 2024-03-27
- FDA Inspection 883834 - 2014-06-18
- FDA Inspection 635269 - 2009-12-16
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