FDA Inspection
Haas SoftwareHaas Software – FDA Inspection, Jul 10, 2013
Record Details
This FDA Inspection record concerns Haas Software, with an inspection on July 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Haas Software
- Inspection Date
- July 10, 2013
- Product Type
- Devices
View Company Profile
ID · a8e0d320-f627-4da8-96b6-e25d4300aed5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840359
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Haas Software
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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