FDA Inspection
Monarch Medical Products IncMonarch Medical Products Inc – FDA Inspection, Jan 20, 2010
Record Details
This FDA Inspection record concerns Monarch Medical Products Inc, with an inspection on January 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Monarch Medical Products Inc
- Inspection Date
- January 20, 2010
- Product Type
- Devices
View Company Profile
ID · 64c175d9-1caa-4aa9-b964-17b5109c3945
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 644647
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)General
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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