Drugs

Multiple Violations at Cantrell Drug Company

FDA has released the FDA-483 from a 9/14-10/14 Dallas District Office inspection at Cantrell Drug Co., an outsourcing facility, showing 12 violations. Specific inspection observations were:

aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
failing to establish, write, and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products;
failing to write and follow test procedures relative to appropriate laboratory testing for sterility and pyrogens;
failing to have a written testing program designed to assess drug product stability characteristics;
failing to have testing and release of drug product for distribution include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient before release;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
the building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, labeling, in-process materials, and drug products, and to prevent contamination;
failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
labels of the facility’s drug products are deficient; and
failing to record and justify deviations from written production and process controls.

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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