Drugs

ImprimisRx NJ FDA-483 Has 9 Observations

FDA has released the form FDA-483 with nine observations from a 7/11-8/5 inspection at ImprimisRx NJ, a Ledgewood, NJ, producer of sterile and non-sterile drug products. The inspection observations were:

the ISO 5 classified aseptic processing areas had visibly dirty equipment or surface;
personnel did not disinfect and change gloves frequently enough to prevent contamination;
materials or supplies were not disinfected before entering the aseptic processing area;
the use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate;
the facility design allowed the influx of poor quality air into a higher classified area;
the segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning;
non-microbial contamination was observed in the production area;
the firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess; and
ISO classified areas were not certified under dynamic conditions.

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