FDA Inspection
Amerx Health Care Corp.Amerx Health Care Corp. – FDA Inspection, Feb 24, 2014
Record Details
This FDA Inspection record concerns Amerx Health Care Corp., with an inspection on February 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amerx Health Care Corp.
- Inspection Date
- February 24, 2014
- Product Type
- Devices
View Company Profile
ID · 823af7eb-51a6-4118-a3ac-10a8b40d6c2f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 869236
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
19- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Showing 10 of 19 citations.
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Other FDA inspections of Amerx Health Care Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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