FDA Inspection
Spartan Bioscience Inc.Spartan Bioscience Inc. – FDA Inspection, Dec 18, 2014
Record Details
This FDA Inspection record concerns Spartan Bioscience Inc., with an inspection on December 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spartan Bioscience Inc.
- Inspection Date
- December 18, 2014
- Product Type
- Devices
View Company Profile
ID · 8f33ecc2-18a6-4c00-93bf-5f82d7720e01
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 908914
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.184DHR content
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