Drugs

Sun Pharma Gets 8-item FDA-483

FDA has issued Sun Pharmaceutical Industries an eight-observation Form 483 after a December inspection at its Gujarat, India drug manufacturing facility. According to the form, the company was cited for not having written procedures for production and process controls designed to assure that its drug products have the identity, strength, quality, and purity they purport to possess.

Sun was also cited for not specifying in writing the responsibilities and procedures applicable to the quality control unit. Specifically, the 483 said the company failed to establish and implement controls which ensure data integrity when using its environmental monitoring computerized system for microbiology samples, including all sterile environmental monitoring. It said the microbiology laboratory failed to establish controls which monitor and prevent all environmental monitoring data from being manipulated.

Additionally, FDA said Sun’s laboratory controls do not include scientifically sound and appropriate test procedures designed to assure that its drug products conform to appropriate standards of identity, strength, quality and purity. And, it said, control procedures are not established which monitor the output of identified manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and drug products.

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