Drugs

Granules Steps Up Oversight at Troubled India Facility

Granules India Ltd is tightening oversight of its manufacturing operations and accelerating digitization efforts based on FDA-documented compliance issues at its largest facility, a company executive told Reuters.

FDA cited the drugmaker last year (see story) in a Warning Letter, noting violations related to record-keeping, equipment cleaning, and contamination controls at its plant in Telangana, India. Inspectors also reported finding torn data records discarded in waste bags, raising concerns about data integrity and adherence to good manufacturing practices.

Executive director Priyanka Chigurupati said the company is moving key documentation — including batch records and operational logs — into digital systems to reduce regulatory risk. Granules is also increasing the frequency of on-site managerial reviews, known as “gemba walks,” to monitor manufacturing practices and address issues in real time.

While the FDA warning has not halted production, it could delay approval of new products from the affected site. The company generates a significant portion of its revenue from the U.S. market.

Chigurupati said Granules is also investing in automation and tighter process controls across its network of facilities as it prepares for a potential follow-up FDA inspection.

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