Drugs

10 Observations in Hospira FDA-483

FDA has released the FDA-483 issued following a 10/16-10/27/17 inspection at a Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations were:

failing to thoroughly review any unexplained discrepancy whether the batch has been already distributed;
employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use;
reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration;
cleaning products designed to prevent microbiological contamination of drug products purporting to be sterile are not followed;
failing to submit a NDA-Field Alert Report within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application;
written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up;
procedures describing handling of written and oral complaints related to drug products are deficiently written;
failing to record and/or justify deviations from written test procedures; and
failing to store drug products under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome