FDA Inspection
X-Ray Support, Inc.X-Ray Support, Inc. – FDA Inspection, May 20, 2011
Record Details
This FDA Inspection record concerns X-Ray Support, Inc., with an inspection on May 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- X-Ray Support, Inc.
- Inspection Date
- May 20, 2011
- Product Type
- Devices
View Company Profile
ID · 8f626d2a-b08c-4989-a6df-ac3442f992b2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 727726
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.186QSR
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