Dr. Reddy’s Laboratories, LTD, Biologics – FDA 483, Sep 12, 2025

During an inspection conducted from September 4 to September 12, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Dr. Reddy"s Laboratories, LTD, Biologics, located in Telangana, India. The inspection identified significant deviations from current good manufacturing practices (CGMP) in their drug substance and drug product manufacturing facility.

Key observations included inadequate procedural controls and oversight for environmental monitoring data, with manual data entry into uncontrolled spreadsheets leading to numerous inaccuracies in reports and trend analyses, hindering the assessment of corrective actions. The firm"s document control system was also found deficient; it permitted downloading of approved documents without embedded signatures, creating a risk of unauthorized modifications and uncontrolled copies.

Furthermore, procedures designed to prevent microbiological contamination of sterile drug products during aseptic filling setup were deemed inadequate. Inspectors observed multiple instances of operators blocking "first air" to sterile surfaces, insufficient post-filling sterility sampling, and the use of non-sterile equipment near sterile components, along with breaches in operator gowning.

Finally, the firm"s viral cross-contamination risk assessment for drug product manufacturing was inadequate, failing to align with industry standards, particularly concerning U.S. market products manufactured in shared facilities alongside non-U.S. market products.

These observations require Dr. Reddy"s Laboratories to implement comprehensive corrective and preventive actions to ensure data integrity, robust document control, effective aseptic processing, and adequate risk mitigation strategies to comply with FDA regulations.