Drugs

8 Observations on Dr. Reddy’s FDA-483

FDA has released the FDA-483 issued following an 8/12-8/20 inspection at the Dr. Reddy’s Laboratories drug manufacturing facility in Andhra, Pradesh, India. The inspection observations were:

the quality control unit lacks authority to fully investigate errors that have occurred;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
deviations from written production and process control procedures are not justified;
aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
equipment for adequate control over air pressure, microorganisms, dust, humidity, and temperature is not provided when appropriate for the manufacture, processing, packing, or holding of a drug product;
each lot of a component, drug product container, and closure that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use;
control procedures are not established that 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; and
there is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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