Fischer Imaging preparing response to FDA warning letter citing quality assurance deficiencies.
This article was originally published in The Gray Sheet
Executive Summary
FISCHER X-RAY QUALITY SYSTEM DEFICIENCIES CITED BY FDA in a March 19 warning letter based on an inspection of Fischer's Denver manufacturing facility Nov. 5 through Dec. 19, 1996. In the five-and-a-half page letter, FDA cites several problems related to Fischer Imaging's quality assurance program for its diagnostic x-ray and mammography systems, such as inadequate procedures "to assure that solutions to quality assurance problems were identified, recommended, or provided, and that implementation of solutions were verified."