FDA Inspection
Ortho-Cycle Company Inc.Ortho-Cycle Company Inc. – FDA Inspection, Mar 13, 2013
Record Details
This FDA Inspection record concerns Ortho-Cycle Company Inc., with an inspection on March 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ortho-Cycle Company Inc.
- Inspection Date
- March 13, 2013
- Product Type
- Devices
View Company Profile
ID · c1580075-de8c-43f7-bfe1-d626d378d6b7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 822950
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, 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 803.17Lack of Written MDR Procedures
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Other FDA inspections of Ortho-Cycle Company Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ortho-Cycle Company Inc.
- FDA Inspection 878180 - 2014-05-06
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