FDA Inspection
Scandinavian Formulas, Inc.Scandinavian Formulas, Inc. – FDA Inspection, Apr 6, 2012
Record Details
This FDA Inspection record concerns Scandinavian Formulas, Inc., with an inspection on April 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Scandinavian Formulas, Inc.
- Inspection Date
- April 6, 2012
- Product Type
- Devices
View Company Profile
ID · bead3873-5fd5-4d1b-be08-f144c4b8e8f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778518
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Scandinavian Formulas, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 25, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 8, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Scandinavian Formulas, Inc.
- FDA Inspection 992913 - 2016-11-21
- FDA Inspection 889678 - 2014-07-25
- FDA Inspection 588181 - 2009-06-08
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