Drugs

10 Observations in Hospira FDA-483

FDA has just released the FDA-483 issued following a 12/9-12/17/20 inspection at the Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations on the form were:

failing to fully follow the responsibilities and procedures applicable to the quality control unit;
failing to establish control procedures that monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production;
failing to follow written production and process control procedures in the execution of production and process control functions;
failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process;
written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up;
acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release;
master production and control records lack complete manufacturing and control instructions and precautions to be followed; and
the company’s examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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