Fischer receives FDA warning letter

April 16, 1997

Fischer Imaging of Denver received a warning letter from the Food and Drug Administration last month for deficiencies in its manufacturing documentation processes. The notification is the second time in two years that Fischer has received a warning

Fischer Imaging of Denver received a warning letter from the Food and Drug Administration last month for deficiencies in its manufacturing documentation processes. The notification is the second time in two years that Fischer has received a warning letter from the agency (SCAN 5/10/95).

The warning letter follows a six-week FDA inspection that took place late last year as part of a routine biennial audit of Fischer's manufacturing facility, according to Sammy Emrich, director of regulatory affairs at Fischer. In the letter, the FDA expressed concern with manufacturing documentation, as well as the methods Fischer uses to determine trends in its manufacturing process.

Fischer is responding to the letter by improving its documentation processes, examining better system reporting, and establishing product improvement teams, Emrich said. The FDA did not find fault with Fischer's products or the manufacturing process itself, she said.

In the warning letter Fischer received two years ago, the FDA cited Fischer for improper follow-up on repairs, inadequate analysis of product failures, and assigning to a single employee both quality assurance and manufacturing functions. Fischer complied with FDA concerns in that case, and the most recent letter commented on some of the improvements Fischer made in response to the first letter.