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Article: Complaint handling procedures cited at Amrex Zetron.(Medical Devices)
- Article from:
- Validation Times
- Article date:
- May 1, 2009
- Author:
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April 14--Los Angeles District
An Oct. 21-Nov. 3 inspection of Amrex Zetron, based in Carson, CA, revealed the company did not have a PMA or IDE for any of its neurological electrotherapy products.
The company did not have adequate complaint handling procedures, the agency wrote. Neither its "Customer-Related Processes. nor "Corrective Action and Preventive Action. procedures included adequate procedures for complaint handling.
Amerx Zetron did not adequately conduct an investigation nor maintain a record of the investigation by the formally designated unit. With respect to a customer complaint, the device identification and control number used ...