Drugs

Cohance Lifescience FDA-483

FDA has released the form FDA-483 issued following an 8/4-8/12 inspection at the Cohance Lifesciences drug manufacturing facility in Secunderabad, Telangana, India. The inspection observations were:

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 had already been distributed;
failure of written records of investigations of a drug complaint to include the follow-up;
failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
failure to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
failure to establish written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product; and
failure to establish the accuracy, sensitivity, and reproducibility of test methods.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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