FDA 483 - Dr. Reddy's Laboratories, Ltd, Biologics - October 12, 2023

This FDA Form 483 details nine observations from an inspection of Dr. Reddy's Laboratories.

**Observation 1:** The viral control strategy for L CbTCl is inadequate, lacking adventitious virus testing on unprocessed bulks for non-US market products, despite sharing common equipment and materials with US market manufacturing, posing a cross-contamination risk. Shared equipment includes upstream/downstream drug substance equipment, specific manufacturing components, housing, and drug product manufacturing equipment.

**Observation 2:** CbT drug substance manufacturing areas exhibit uncontrolled mold. There were 696 mold recoveries since January 2021 (157 in 2021, 372 in 2022, 167 in 2023). Action limits (Grade C >H4CFU, Grade D 6lf 41cFU) are insufficient. Mold contaminants from environmental monitoring (166 settle plate, 521 active air, 9 surface since Jan 2021) have not been meaningfully trended, and no investigations or CAPAs were implemented for recurring recoveries.

**Observation 3:** Investigations and corrective actions for visual inspection limit excursions are inadequate for defective Chm drug product trends. Extrinsic fibers are classified as major defects despite potential higher risk. Atypical trends (fibers in 45/ ~1 batches, black particles in 17/ ~ batches) were