Drugs

10 Observations in Toyobo FDA-483

FDA has released the FDA-483 issued following a 2/15-2/25 inspection at Toyobo Co., Otsu, Shiga, Japan. The 10 inspection observations on the document are:

failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
production personnel were not practicing good sanitation and health habits;
laboratory records do not include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
failing to follow written production and process control procedures in the execution of production and process control functions;
failing to include conclusions and follow-up in the written records of investigations into unexplained discrepancies;
failing to verify under actual conditions of use the suitability of all testing materials;
failing to put in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
failing to have batch production and control records to include the weights and measures of components used in the course of processing each batch of drug product produced;
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel.

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