FDA Inspection
Monarch Molding IncMonarch Molding Inc – FDA Inspection, Dec 16, 2009
Record Details
This FDA Inspection record concerns Monarch Molding Inc, with an inspection on December 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Monarch Molding Inc
- Inspection Date
- December 16, 2009
- Product Type
- Devices
View Company Profile
ID · 0233f596-c6b4-4d9b-8e34-aa4ef07c6aa5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635269
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR 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 |
| 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 |
Other documents for Monarch Molding Inc
- FDA Inspection 1234299 - 2024-03-27
- FDA Inspection 1006141 - 2017-03-16
- FDA Inspection 883834 - 2014-06-18
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