Drugs

Hetero Drugs FDA-483

FDA has released the FDA-483 issued following a 2/26-3/2 inspection at Hetero Drugs, a Sangareddy District, India, active pharmaceutical ingredient producer. The form says specific inspection observations were:

failing to thoroughly review any unexplained discrepancy and failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed;
failing to fully follow responsibilities and procedures applicable to the quality control unit;
employees engaged in the processing, holding, and testing of a drug product lack the training and experience required to perform their assigned functions;
there is no assurance that equipment used in the production of a specific active pharmaceutical ingredient are always maintained and/or kept in proper conditions for manufacturing operations and to prevent the contamination of the products handled and/or processed by the equipment; and
separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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