Drugs

9 Observations in Qualgen FDA-483

FDA has released the form FDA-483 issued following a 9/13-9/30 inspection at the Qualgen sterile drug production facility in Edmond, OK. The nine inspection observations were:

failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
failing to follow written procedures that describe the examinations to be conducted on appropriate samples of in-process materials for each batch;
failing to reject drug products failing to meet established specifications;
failing to follow procedures describing the handling of all written and oral complaints regarding a drug product;
failing to have procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process;
failing to have laboratory controls include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to have written procedures for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment;
failing to have batch production and control records to include complete information relating to the production and control of each batch; and
the labels of the outsourcing facility’s drug products are deficient.

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