Drugs

Juno Therapeutics FDA-483

FDA has published the FDA-483 with six inspection observations issued following a 10/7-10/16 agency inspection at Juno Therapeutics, Bothell, WA. The firm is a CAR-T cell therapy manufacturer. The specific inspection observations were:

failing to thoroughly review any unexplained discrepancy, failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failing to include appropriate conclusions and follow-up in written records of investigations into unexplained discrepancies or the failure of a batch or any of its components to meet specifications;
failing to include required materials in the written procedure for manufacturing material visual inspection;
failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failing of laboratory controls to include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to justify deviations from written test procedures to assure compliance with established specifications and standards.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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