FDA 483 - Lupin Limited (Biotech Division) - October 14, 2022

This FDA Form 483 details numerous deficiencies observed during an inspection of a drug product manufacturing facility.

**Facility and Operations:** The inspection focused on aseptic monitoring for a fill line (EQP/DPD/001) used for drug product manufacture, including RABS (Restricted Access Barrier System) and surrounding Grade A/B areas. It also covered raw material handling, utility systems (e.g., water for injection), and quality control laboratories.

**Violations and Observations:** * **Aseptic Monitoring Inadequacies:** Settling plate placement and exchange procedures in RABS were inadequate, leading to excessive interventions. Personnel environmental monitoring was not representative. * **Product Evaluation Deficiencies:** Failure to adequately evaluate and take remedial action for actionable microbial contamination in a Grade A area (e.g., 4 CFU Acrococei Viridans, a human pathogen, with no further testing). * **Environmental Monitoring Deficiencies:** * Grade A surrounding areas not monitored to Grade A standards (e.g., nonviable particle and active air monitoring not dynamic, limited settle plate placement). * Active air sampling not conducted dynamically in RABS during filling. * Personnel performing RABS interventions not consistently monitored. * Sterilized components unwrapped outside RABS in Grade A surrounding area. * Lack of environmental monitoring in frequently touched/high-traffic areas (e.g