Drugs

12 Catalent Inspection Observations

FDA has released the form FDA-483 issued following an 8/1-9/1/22 inspection at Catalent Indiana, a sterile human drug and biologic product manufacturer in Bloomington, IN. The 12 specific inspection observations were:

failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up;
failing to establish control procedures that monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
acceptance criteria for the sampling and testing conducted by the quality control unit are not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release;
equipment used in the manufacturing of a drug product is not of appropriate design to facilitate operations for its intended use;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed;
routine checking of equipment is not performed according to a written program designed to assure proper performance;
failing to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
in-process samples are not representative;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the aseptic process;
records are not maintained so that data therein may be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures; and
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed so that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

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