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Medical Devices / Inspections and Audits

Thermogram Hit for CAPA, Complaint Handling

Jan. 23, 2019

The FDA cited Thermogram Assessment Services for problems with its CAPA, complaint-handling and MDR procedures.

The agency inspected Thermogram’s Dallas facility in October 2018 and found it lacked a CAPA procedure or complaint handling procedure, according to the Form 483. The agency investigator found the facility lacked compliant process control procedures to ensure conformance to specifications.

In addition, the company lacked procedures for medical device reporting and for purchasing controls to ensure all received products and services met specified requirements.

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