Devices

QS Violations Found in Valeant Inspection

An 8/23-9/1 FDA inspection at Valeant Pharmaceuticals’ Rochester, NY, facility found Quality System Regulation violations in the firm’s work as a specification developer and distributor of the Small Particle Size Aerosol Generator, a nebulizer pneumatic flow system for administering Virazole ( ribavirin) aerosol and the OraPharma ONSET mixing pen, a high precision compounding and dispensing device for mixing two solutions together. An 11/3 Warning Letter from the agency’s New York District Office says that specific violations included:

failing to establish and maintain procedures for validating the device design;
failing to establish and maintain procedures for identifying, documenting, validating or, where appropriate, verifying, reviewing, and approving design changes before their implementation;
failing to establish and maintain procedures for implementing corrective and preventive action;
failing to establish and maintain procedures for controlling product that does not conform to specified requirements; and
failing to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with regulatory requirements.

The firm’s responses were not adequate or only partially adequate, FDA says. Valeant was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and 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

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