FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The ...
SALT LAKE CITY, March 04, 2025 (GLOBE NEWSWIRE) -- Nelson Labs, a Sotera Health company and a global leader in microbiological and analytical chemistry testing and advisory services for the medical ...
Drugmakers using a sterility assurance release program can take a pass on sterility testing of finished units, according to FDA guidance. In a parametric release program, a drugmaker's demonstrated ...
Understand the immediate actions to be taken in the event of a sterility test failure Review the focal points for the laboratory failure investigations, from reviewing training to isolator controls ...
Understand the immediate actions to be taken in the event of a sterility test failure Review the focal points for the laboratory failure investigations, from reviewing training to isolator controls ...