FDA Inspection
Zander Scientific, Inc.Zander Scientific, Inc. – FDA Inspection, Jul 14, 2010
Record Details
This FDA Inspection record concerns Zander Scientific, Inc., with an inspection on July 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zander Scientific, Inc.
- Inspection Date
- July 14, 2010
- Product Type
- Devices
View Company Profile
ID · 95b961b0-13b1-4a55-a267-496e8e0337d7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 672076
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate 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 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zander Scientific, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 25, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zander Scientific, Inc.
- FDA Inspection 828655 - 2013-04-22
- FDA Inspection 745842 - 2011-08-25
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