Drugs

Sun Pharma Hit With 483 After India Inspection

A two-week December FDA inspection of Sun Pharmaceutical Industries’ Dadra, Dadra & Nagar Haveli and Daman, India facilities led to a six-observation FDA Form-483 that has cited the firm for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. “Specifically, your laboratory investigations pertaining to out-of-specification investigations are not thoroughly investigated to determine the root cause(s) for long-term stability sample failures for the drug products sold into the U.S. market,” the document says.

Another observation cited in the 483 involved equipment and utensils that were not cleaned and maintained at appropriate intervals to prevent contamination. Additionally, FDA said the responsibilities and procedures applicable to the quality control unit were not in writing and fully followed. For example, it said the quality unit’s oversight was lacking on the issuance, handling, retrieval and reconciliation of GMP documents used in the manufacturing of drug products. Further, controlled documents related to certain departments could be printed from the electronic document management system without any oversight of the quality unit.

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