FDA 483 - Catalent Indiana, LLC - September 02, 2020

This FDA Form 483 document details observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed three key deficiencies related to quality systems and manufacturing controls.

Observation 1 indicates that the firm failed to establish adequate procedures for the cleaning and maintenance of equipment. This suggests a lack of documented and implemented processes to ensure equipment is properly cleaned and maintained, which is critical for preventing cross-contamination and ensuring product quality.

Observation 2 states that the firm did not adequately validate the manufacturing process for Drug X. Process validation is a regulatory requirement to ensure that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes. The absence of adequate validation raises concerns about the consistency and quality of Drug X.

Observation 3 highlights that the firm did not have proper controls in place to prevent contamination of products. This is a critical finding as it directly impacts product safety and efficacy. Inadequate contamination controls can lead to microbial, particulate, or chemical contamination, posing significant risks to patients.

Collectively, these observations point to deficiencies in the facility's quality management system, specifically concerning equipment management, process validation, and contamination control. These issues have significant business and operational implications, potentially leading to product recalls, regulatory actions, and damage to the firm's reputation. The firm is required to respond to these observations with a corrective action plan.