Drugs

FDA Form 483 Issued to Texas Drug Compounder

FDA has posted a Form 483 from a December inspection of drug compounder Elkhart Pharmacy (Elkhart, TX). The inspection cited the firm over its aseptic processing areas and the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. “Specifically, your firm does not use a sporicidal agent or sterile wipes during the sanitation of the IS0-5 Laminar Airflow Hood, located in the IS0-7 classified sterile drug preparation room, where all sterile drug products are prepared,” the form says.

The inspection also cited Elkhart for its employees not wearing protective apparel to protect drug products from contamination. For example, the agency says the compounder “does not use, nor does it provide, sterile hair nets, sterile face masks, sterile beard nets, sterile eye wear, sterile gowns, or sterile boot covers for employees preparing sterile drug products.”

Additionally, the 483 says results from stability testing are not used in determining expiration dates. It says Elkhart sends products to an outside contractor for sterility testing but it does not base the expiration dates on the contractor’s findings.

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

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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