FDA Inspection
CAS Medical Systems, Inc.CAS Medical Systems, Inc. – FDA Inspection, Apr 22, 2016
Record Details
This FDA Inspection record concerns CAS Medical Systems, Inc., with an inspection on April 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CAS Medical Systems, Inc.
- Inspection Date
- April 22, 2016
- Product Type
- Devices
View Company Profile
ID · 5235cfb1-fcf9-45a1-a5d8-0521d52ec207
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 968321
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CAS Medical Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CAS Medical Systems, Inc.
- FDA Inspection 823320 - 2013-03-14
- FDA Inspection 679409 - 2010-08-20
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