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Medical Devices / Inspections and Audits

Texas Specifications Developer Hit for Missing Procedures

Jan. 29, 2019
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The FDA cited Thermogram Assessment Services, a Dallas, Texas specifications developer, for procedures it failed to establish at its facility.

The FDA investigator noted during their Oct. 26-31, 2018 inspection that the firm lacked procedures for CAPAs and complaint handling.

In addition, the firm had no production processes in place to ensure product conformance and was missing a medical device reporting procedure and a purchasing controls procedure.

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