Drugs

19-Page Exela Pharma Sciences FDA-483

FDA has released the 19-page form FDA-483 issued following an 11/4-11/15/2024 inspection at Exela Pharma Sciences, a Lenoir, NC, outsourcing and sterile drug manufacturing facility. The form’s 15 inspection observations were:

failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up;
failure to fully follow the responsibilities and procedures applicable to the quality control unit;
failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure of laboratory records to include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness;
failure to exercise appropriate controls over computers or related systems to ensure that changes in master production and control records or other records are instituted only by authorized personnel;
failure to perform calibration of instruments and recording devices at suitable intervals following an established written program;
failure of laboratory records to include complete records of any testing and standardization of laboratory standard solutions;
failure to follow and document established laboratory control mechanisms at the time of performance;
failure to have a written testing program designed to assess the stability characteristics of drug products;
employees engaged in the manufacture and processing of drug products lack the training required to perform their assigned functions;
failure of the statistical quality control criteria to include appropriate rejection levels;
separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers, and closures before disposition;
separate or defined areas to prevent contamination or mix-ups are deficient related to the receipt, identification, storage, and withholding from use of components, drug product containers, and closures pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging;
labels of the outsourcing facility’s drug products are deficient; and
failure to follow written production and process control procedures in the execution of production and process control functions.

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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