Drugs

FDA-483 from 2 Aurobindo Unit Inspections

FDA has released the FDA-483s issued following inspections at Aurobindo Pharma Units 5 and 8. The inspection at Unit 5 in Telangana, India, ran from 10/21-10/28 and resulted in four inspection observations:

laboratory controls do not always include the establishment of scientifically sound and appropriate procedures designed to assure that drug substances conform to appropriate standards of identity, strength, quality, and purity;
equipment for adequate control over microorganisms is not always provided when appropriate for the manufacture, processing, and packing of drug substances;
the aseptic processing area is deficient regarding the system for monitoring environmental conditions; and
process validation does not always include inclusion and establishment of all process parameters that should be controlled for reproducible operations.

The inspection at Unit 8, also in Telangana, ran from 10/21 to 10/25 and yielded four observations:

written procedures are not established to assure that equipment is clean prior to use, where full verification of cleaning is not conducted between production batches;
investigations into critical deviations are not always thorough including appropriate follow-up, and/or fully documented;
the responsibility and procedures applicable to the Quality Unit are not established or fully followed; and
batch production and control records do not always include complete information and data relating to the production and control of each batch.

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