Drugs

Central Admixture Pharmacy FDA-483

FDA has released the FDA-483 issued following a 2/14-2/25 inspection at Central Admixture Pharmacy Services, a Phoenix, AZ, outsourcing facility. The six inspection observations were:

procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
laboratory records do not include a record of all calculations performed in connection with the test;
appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality, or purity of the drug product; and
failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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