Drugs

Intact Pharmaceuticals FDA-483 Out

FDA has released the FDA-483 issued following a 9/10-10/12/18 inspection at Intact Pharmaceuticals, an outsourcing facility in New Milford, CT. The 11 inspection observations were:

aseptic processing areas are deficient regarding systems for maintaining any equipment used to control aseptic conditions;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic process;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
responsibilities and procedures applicable to the quality control unit are not fully followed;
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 and processing of drug products is not appropriate for the duties they perform;
individuals responsible for supervising the manufacture and processing of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess;
routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance; and
equipment surfaces that contact drug products are reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

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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