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Theqmnweeklybulletin

Sept. 21, 2012

Vol. 4 No. 38

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Smiths Recalls Infusion Pump for Software Woes

Smiths Medical Medfusion 4000 syringe infusion pumps are being recalled due to a software problem. Read More

Industry Fears FDA May Monkey With ‘Independent’ Audit of Reviews

Drugmakers worry that the FDA doesn’t plan to conduct an honest review of its new drug review program in an upcoming audit. Read More

FDA Warning to Hospira Infusion Plant May Hint at Broader Problems

An FDA warning letter issued to Hospira’s infusion pump plant in Costa Rica may be emblematic of broader companywide manufacturing issues, analysts say. Read More

Clinical Trials Should Deal With Reimbursement Concerns Sooner: Study

Drugmakers’ health economics and outcomes research teams must provide earlier input on clinical trials so the data generated have a better chance of ensuring reimbursement for treatments after approval, according to a new study. Read More

Bedford Broadens Recall of Chemotherapy Drug

Ben Venue subsidiary Bedford Laboratories is expanding its voluntary recall of chemotherapy drug leucovorin calcium due to crystalline particulates in a small number of vials. Read More

BioMerieux Warned Over CAPA, Rework Procedures

The FDA has warned BioMerieux for several violations related to rework procedures and corrective and preventive actions (CAPA) for its microbial detection systems. Read More

Florida CMO Flagged by FDA for Unjustified Process Deviations

Axara Pharmaceuticals has not justified deviations from process control procedures that resulted in drug products gone astray and equipment cleaning confusion, according to an FDA Form 483. Read More

Dynatronics Lands 15-Count 483 on CAPA, Procedural Problems

An FDA inspector’s determination that a single product at Dynatronics’ Ooltewah, Tenn., manufacturing plant fit Class II requirements triggered a 15-count Form 483 at the conclusion of a May 21-23 inspection, company President Kelwyn Cullimore Jr., said. Read More