Drugs

13 Observations in ProRx FDA-483

FDA has released the form FDA-483 issued following a 7/15-8/2 inspection at ProRx, an Exton, PA, outsourcing facility. The 13 inspection observations were:

failure to establish, write, and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
failure to include adequate validation of the aseptic and sterilization process in procedures to prevent microbiological contamination of drug products purporting to be sterile;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
responsibilities and procedures applicable to the quality control unit are not adequate;
failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropriate for the duties they perform;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
buildings used in the manufacture, processing, packing, or holding of drug products are not free of infestation by rodents, birds, insects, and other vermin;
equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance;
failure to maintain a written testing program to assess the stability characteristics of drug products;
reports from analysis from component suppliers are accepted instead of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals;
outsourcing facility labels do not include required information; and
failure to submit a report to FDA on initial registration as an outsourcing facility identifying the drugs compounded during the previous six months.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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