FDA Inspection
Davis Schottlander and Davis, Ltd.Davis Schottlander and Davis, Ltd. – FDA Inspection, Sep 24, 2015
Record Details
This FDA Inspection record concerns Davis Schottlander and Davis, Ltd., with an inspection on September 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 24, 2015
- Product Type
- Devices
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ID · e9ae3127-01f3-447e-b77c-0458dccfb1af
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 944001
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.40(b)Change records, content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Davis Schottlander and Davis, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Davis Schottlander and Davis, Ltd.
- FDA Inspection 665098 - 2010-06-03
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