Drugs

Dignity Health FDA-483 Released

FDA has released the FDA-483 issued at the end of a 10/23-11/1 agency inspection at Northridge Hospital’s Dignity Health sterile drug products producer in Northridge, CA. Specific inspection observations were:

the facility design allowed the influx of poor quality air into a highly classified area;
sinks or drains were present in the classroom where the ISO 5 classified aseptic processing area was located;
the ISO 5 classified aseptic processing area was located within a non-classified room (segregated production area);
unsealed, loose ceiling tiles were observed in the cloakroom;
the facility was designed and/or operated in a way that permits poor flow of personnel;
sporicidal agents were not used in the facility’s clean rooms and/or ISO 5 classified aseptic processing area;
materials or supplies were not disinfected before entering the aseptic processing area;
disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile;
personnel engaged in aseptic processes were observed with exposed hair; and
the segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.

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