Drugs

9 Aurobindo Pharma Inspection Observations

FDA released 3/6 the FDA-483 issued following a 2/12-2/20 agency inspection at Aurobindo Pharma, Telagana, India. The nine inspection observations on the form are:

· aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
· equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use;
buildings used in the manufacture, processing, packing, or holding of drug products are not free of infestation by rodents, birds, insect, and other vermin;
procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance;
employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned function;
· the statistical quality control criteria fail to include appropriate acceptance levels and rejection levels;
established laboratory control mechanisms are not followed and documented at the time of performance; and
appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel.

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