Fischer Imaging preparing response to FDA warning letter citing quality assurance deficiencies.
This article was originally published in The Gray Sheet
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."
You may also be interested in...
Oxford University/AstraZeneca’s COVID-19 vaccine cuts the spread of the virus by 60%, apart from having 70% efficacy in reducing infections in vaccinated individuals. While that is good news for their Indian partner, Serum Institute, the 90% efficacy shown in a subset due to a dosing error causes a dilemma.
After announcing positive topline Phase II results for its Alzheimer’s candidate late last year, Korea's GemVax releases additional data showing significant improvement in secondary outcomes, further raising expectations for the novel peptide drug.
The US FDA’s decision to ask on device adverse event reports whether the device involved had been serviced by a third party could help the agency as well as device makers, says Ricki Chase, compliance practice director at Lachman Consultant Services.