Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL,
Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL, radiopharmaceutical manufacturing facility. It cited Nycomed Amersham for neglecting to maintain FDA standards in the clean room in which NeoScan, indium DTPA, and thallous chloride are manufactured.
In addition, the letter raised concerns about Nycomed Amersham's ability to confirm the sterility of the agent technetium Tc 99m following reprocessing procedures, as well as the company's lack of standard protocols for cleaning and maintaining manufacturing equipment. The company is working closely to resolve the FDA's concerns, and there has not been any interruption of product deliveries, according to Carol Perlman, Nycomed spokesperson.
Study Assesses Lung CT-Based AI Models for Predicting Interstitial Lung Abnormality
September 6th 2024A machine-learning-based model demonstrated an 87 percent area under the curve and a 90 percent specificity rate for predicting interstitial lung abnormality on CT scans, according to new research.