Drugs

Staska Multiple Outsourcing Facility Violations

A 9/3-9/18/2024 FDA inspection at Staska Pharmaceuticals, an outsourcing facility in Bennet, NE, found that the drug products produced failed to meet the legal conditions necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act. The inspection also found serious deficiencies in Staska’s practices for producing drug products intended or expected to be sterile. A just-released 5/5 Warning Letter says specific violations were:

Failure to meet the conditions of Section 503B;
sterile drug products were prepared, packed, or held under insanitary conditions so they may have become contaminated with filth or rendered injurious to health, causing the products to be adulterated; and
failure to have FDA-approved applications for drug products being compounded;
drug products were misbranded due to labeling that does not bear adequate directions for their intended uses.

FDA says it was unable to evaluate some of the company’s corrective actions due to a lack of adequate supporting documentation. It also says some of the corrective actions appeared to be deficient.

Staska was told to respond with a list of specific actions it has 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