Drugs

Violations at India’s Granules Omnichem

FDA has released an FDA-483 issued following a 12/5-12/9/16 inspection at Granules Omnichem Private Limited, Visakhapatnarn, India. The document lists these deviations from current good manufacturing practice regulations for active pharmaceutical ingredients:

failure of the quality unit to ensure review of all deviations reported during production before final product batch release;
failing to train an employee before conducting cleaning of the microbiology laboratory ISO Class 8 room;
failure of the change control system to evaluate and reflect all changes that may affect the production of the finished product;
failing to have complete production master batch records;
failing to have laboratory control records include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays;
facility design and maintenance increases the potential for contamination of equipment and product; and
failing to handle and store materials in a way to prevent degradation, contamination, and cross-contamination.

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