Drugs

Catalent Indiana FDA-483

FDA has released the form FDA-483 issued following a 10/31-11/15/2023 inspection at the Catalent Indiana drug manufacturing facility in Bloomington, IN. The inspection observations were:

failing to fully follow the responsibilities and procedures applicable to the quality control unit;
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;
failing to include adequate validation of the aseptic process in procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile;
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;
failing to have laboratory controls include the establishment of scientifically sound and appropriate test procedures to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.

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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