FDA Inspection
Andonian Cryogenics, Inc.Andonian Cryogenics, Inc. – FDA Inspection, Jun 30, 2010
Record Details
This FDA Inspection record concerns Andonian Cryogenics, Inc., with an inspection on June 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Andonian Cryogenics, Inc.
- Inspection Date
- June 30, 2010
- Product Type
- Devices
View Company Profile
ID · e9647c34-e4c9-40a9-bc70-e3ad0099ae9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 674439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.72(b)(2)Calibration documentation
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