FDA Inspection
Amerx Health Care Corp.Amerx Health Care Corp. – FDA Inspection, Apr 8, 2016
Record Details
This FDA Inspection record concerns Amerx Health Care Corp., with an inspection on April 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amerx Health Care Corp.
- Inspection Date
- April 8, 2016
- Product Type
- Devices
View Company Profile
ID · 61e2f8f5-ca71-47d5-9d46-b74d4ea8a397
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966752
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.184DHR content
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Amerx Health Care Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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