FDA Inspection
ARKRAY Factory, Inc.ARKRAY Factory, Inc. – FDA Inspection, Feb 13, 2009
Record Details
This FDA Inspection record concerns ARKRAY Factory, Inc., with an inspection on February 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ARKRAY Factory, Inc.
- Inspection Date
- February 13, 2009
- Product Type
- Devices
View Company Profile
ID · e62490d2-fc8f-4be1-b89f-bfa50e0320a1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 569079
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.100(a)Lack of or inadequate procedures
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