FDA Inspection
SciVolutions Medical, Inc.SciVolutions Medical, Inc. – FDA Inspection, Aug 4, 2014
Record Details
This FDA Inspection record concerns SciVolutions Medical, Inc., with an inspection on August 4, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SciVolutions Medical, Inc.
- Inspection Date
- August 4, 2014
- Product Type
- Devices
View Company Profile
ID · a4ee0548-06a5-4e87-8f39-d39dfab854d4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 890270
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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