Drugs

14 Observations in Qualgen FDA-483

FDA has released the form FDA-483 issued following a 2/6-3/19 inspection at the Qualgen outsourcing facility in Edmond, OK. The 14 inspection observations were:

failure to fully follow the responsibilities and procedures applicable to the quality control unit;
failure to follow procedures describing the handling of all written and oral complaints about a drug product;
failure 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 been already distributed;
failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure to have written procedures providing cleaning schedules and describing in sufficient detail the methods, equipment, and materials to be used for sanitation;
failure to routinely calibrate automatic, mechanical, and electronic equipment according to a written program designed to assure proper performance;
failure to maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process;
batch production and control records are deficient in that they do not include complete labeling control records, specimens, and copies of labeling;
failure to follow written procedures describing in sufficient detail the controls employed for the issuance of labeling;
failure of master production and control records to include a description of the drug product containers, closures, and packaging materials; and
employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.

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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