FDA Inspection
Alfa Scientific Designs IncAlfa Scientific Designs Inc – FDA Inspection, Jun 20, 2013
Record Details
This FDA Inspection record concerns Alfa Scientific Designs Inc, with an inspection on June 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alfa Scientific Designs Inc
- Inspection Date
- June 20, 2013
- Product Type
- Devices
View Company Profile
ID · 001ba9d5-c10d-4bf5-bdcf-a1f4da5bf5d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838601
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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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 |
| March 31, 2009 | 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 572522 - 2009-03-31
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