www.fdanews.com/articles/190012-texas-specifications-developer-hit-for-missing-procedures
Texas Specifications Developer Hit for Missing Procedures
January 28, 2019
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.