FDA Inspection
Monster Medic IncMonster Medic Inc – FDA Inspection, Aug 13, 2009
Record Details
This FDA Inspection record concerns Monster Medic Inc, with an inspection on August 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Monster Medic Inc
- Inspection Date
- August 13, 2009
- Product Type
- Devices
View Company Profile
ID · 1fa08809-c4e0-4aba-b7af-da1634f83415
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606522
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)(4)Approval of process
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.184DHR content
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