Drugs

11 Observations in Eugia Pharma Inspection

FDA has released a 29-page form FDA-483 with 11 observations from a 1/27-2/6 inspection at the Eugia Pharma Specialties sterile drug product manufacturing facility in Sangareddy, Telangana, India. The inspection observations were:

failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile, to include adequate validation of the aseptic process;
failure to fully follow the responsibilities and procedures of the quality control unit;
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 has already been distributed;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
failure of testing and release of drug product for distribution to include appropriate laboratory determination of satisfactory conformance to the final specifications before release;
failure to train employees in the particular operations they perform as part of their function;
failure to follow test procedures relative to appropriate laboratory testing for pyrogens;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
failure of laboratory records to include the initials or signature of a second person showing that the original records have been reviewed for accuracy; and
failure to follow established laboratory control mechanisms.

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