FDA Inspection
Alcor Scientific, Inc.Alcor Scientific, Inc. – FDA Inspection, Dec 31, 2009
Record Details
This FDA Inspection record concerns Alcor Scientific, Inc., with an inspection on December 31, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alcor Scientific, Inc.
- Inspection Date
- December 31, 2009
- Product Type
- Devices
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ID · 9c48e080-e1d7-42d2-a93c-6addcc818bb9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 638618
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(a)(2)Oral complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Alcor Scientific, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alcor Scientific, Inc.
- FDA Inspection 1074839 - 2018-12-18
- FDA Inspection 782014 - 2012-05-09
- FDA Inspection 718263 - 2011-03-30
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