Multiple Violations on Catalent FDA-483

A just-released FDA-483 issued following a 3/14-3/25 inspection at Catalent Pharma Solutions, St. Petersburg, FL, lists 14 violations, including:
failing 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;failing to submit an NDA field alert report within the required time of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product;failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;failing to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;failing to have the responsibilities and procedures applicable to the quality control unit in writing and fully followed;failing to follow written production and process control procedures in the execution of production and process control functions and documented at the time of performance;failing to adequately supervise component weighing operations;failing to have sufficient controls systems necessary to prevent contamination or mix-ups;failing to train employees in the particular operations they perform as part of their function;failing of laboratory controls to include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity;failing to sufficiently write or follow procedures describing the calibration of instruments, apparatus, gauges, and recording devices;failing to follow and document at the time of performance established test procedures and laboratory control mechanisms; andfailing to develop written procedures for the receipt and evaluation of post-marketing adverse drug experiences.