FDA Inspection
Medical Soft IncMedical Soft Inc – FDA Inspection, Oct 16, 2018
Record Details
This FDA Inspection record concerns Medical Soft Inc, with an inspection on October 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e91d7732-6533-485c-a5eb-526c1ad252fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069381
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Medical Soft Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 30, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Soft Inc
- FDA Inspection 861976 - 2014-01-10
- FDA Inspection 653969 - 2010-03-30
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