Drugs

Velocity Marketed Adulterated Eye Drops: FDA

FDA says it inspected the Velocity Pharma drug manufacturing facility in Melville, NY, from 11/3-12/14/2023 after an agency inspection at Velocity’s ophthalmic drug contract manufacturer, Kilitch Healthcare India Limited, found violative conditions. A just-released 7/17 Warning Letter to Velocity says the Kilitch current good manufacturing practice (CGMP) violations caused its drug products to be adulterated.

FDA told Velocity that the inspection of its facility determined that it distributes certain eye drop products under several brand names. It says that Velocity’s receipt in interstate commerce of adulterated drugs and the delivery of such drugs is a violation of the Federal Food, Drug, and Cosmetic Act.

The letter says that while Velocity used a contract manufacturer for its ophthalmic drug products, it failed to have adequate procedures to ensure all ophthalmic drug products received from Kilitch and a redacted source were manufactured in compliance with CGMP regulations.

Velocity was told to provide a detailed plan to ensure that it does not receive or deliver adulterated drugs in interstate commerce.

The letter also notes that Velocity has inadequate distribution records and delayed a recall of affected products.

Velocity was told to promptly correct any violations and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

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