Drugs

Inspection Again Cites Indian Drug Firm Wockhardt

An FDA inspection has again cited Indian drug firm Wockhardt Ltd. for manufacturing violations. In 2013, a Warning Letter cited significant GMP violations, including data integrity concerns, for finished pharmaceuticals at the company’s manufacturing facilities in Chikalthana and Waluj. Two days after the letter was issued, the agency announced an import alert for many of the generic drugs manufactured at Chikalthana.

Now, the company says a recent inspection produced a Form 483 at its Shendra plant in western India. FDA listed nine undisclosed observations, Wockhardt said in a regulatory filing, adding that a response is being prepared The Shendra manufacturing unit is a new facility and the company says that currently no products from there are being exported to the U.S. market.

Last year, Wockhardt said it had corrected GMP deficiencies cited during the Chikalthana inspection. An inspection at the time reportedly did not find any issues with respect to data security and control measures at the facility and urged the firm to continue with its compliance efforts to achieve the “desired quality culture.” That inspection did list some Form 483 observations, but these were on products manufactured prior to Wockhardt implementing its GMP remediation program, the company said. “The efforts for data security control have been thoroughly verified during the inspection and have been appreciated as it is qualified and executed since September 2013,” it added.

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

Read more

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