FDA Inspection
Alfa Scientific Designs IncAlfa Scientific Designs Inc – FDA Inspection, Mar 31, 2009
Record Details
This FDA Inspection record concerns Alfa Scientific Designs Inc, with an inspection on March 31, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alfa Scientific Designs Inc
- Inspection Date
- March 31, 2009
- Product Type
- Devices
View Company Profile
ID · 45de1713-848c-4290-bd20-c9835b9a70a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 572522
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
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Other FDA inspections of Alfa Scientific Designs Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alfa Scientific Designs Inc
- FDA Inspection 1061526 - 2018-07-27
- FDA Inspection 1025886 - 2017-08-25
- FDA Inspection 838601 - 2013-06-20
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