Fischer receives FDA warning letter
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.
Newsletter
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
Study Shows Enhanced Diagnosis of Coronary Artery Stenosis with Photon-Counting CTA
July 10th 2025In a new study comparing standard resolution and ultra-high resolution modes for patients undergoing coronary CTA with photon-counting detector CT, researchers found that segment-level sensitivity and accuracy rates for diagnosing coronary artery stenosis were consistently > 89.6 percent.
FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
July 9th 2025For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.
