Catalent Indiana, LLC — FDA 483 Findings

Records are not maintained so that data therein can be reviewed at least <Redacted B4> to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.

Routine checking of equipment is not performed -according to a written program designed to assure proper performance.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Your firm failed 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.

Control procedures are not established which 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.

Equipment used in the manufacturing of a drug product is not of appropriate design to facilitate operations for its intended use.

ln-process samples are not representative.

Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed.

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

Your firm failed 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.