Drugs

FDA-483 Shows Violations at India’s Hetero Labs

FDA has released the FDA-483 issued after a 12/7-12/16/16 agency inspection at Hetero Labs, Polepally Village, India. Inspection observations included:

failing to fully follow the responsibilities and procedures applicable to the quality control unit;
failing to prepare batch production and control records for each batch of drug product and failing to include in them complete information relating to the production and control of each batch;
failing to include in written records of investigation of a drug complaint the findings of the investigation and the follow-up;
failing to maintain at the establishment where an investigation occurred the written record or copy of the record of an investigation of a complaint conducted in relation to any unexplained discrepancy;
failing to clean and maintain at appropriate intervals equipment and utensils to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
failing to document deviations from production time limits;
failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; and
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other 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