Drugs

FDA Warns Overseas OTC Manufacturers

FDA has warned six overseas over-the-counter drug manufacturers about significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. In each instance, based on a review of records requested from the companies and other information, the 8/3 Warning Letters cited these violations:

failing to conduct at least one test to verify the identity of each component of a drug product; and
failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

The letters were sent to:

Fancystage Unipessoal, Porto, Portugal;
Avaria Health & Beauty Corp., Cambridge, Ontario, Canada;
LLC Ltd., Chungcheongbuk-do, South Korea;
Suhan Aerosol, Maharashtra, India;
Orchid Lifesciences, Ahmedabad, Kathwada, India; and
Tan Alize Kosmetik Ve Temizlik Urunleri, Cekmekoy/Istanbul, Turkey.

The agency recommends that each of the companies engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The consultant should also perform a six-system audit of the companies’ operation for CGMP compliance and the efficacy of their corrective and preventive actions before the firms pursue resolution of their compliance status with FDA.

The firms were all placed on import alerts. They were told to respond with a list of specific steps they have taken to address the 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