Drugs

CGMP Problems Found at Keshava Organics

A 5/25-5/31/17 FDA inspection at Keshava Organics, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients. A 3/15 Warning Letter says the specific deviations were:

failing to adequately investigate out-of-specification results and to implement appropriate corrective actions; and
failing to maintain complete laboratory control records for test methods.

The letter notes the agency found similar CGMP deficiencies in 2011 and 2014 inspections. “These recurring deficiencies demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate,” it says. FDA recommends that Keshava engage a qualified consultant to assist it in meeting CGMP requirements. It says the third-party consultant should comprehensively audit and assist with remediating the firm’s operations, including investigations, laboratory controls, data management systems, quality unit authorities and resources, and all other quality system elements.

The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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