FDA 483 - Eli Lilly & Company - October 21, 2022

On October 21, 2022, the FDA issued a Form 483 to Eli Lilly and Company, located at Lilly Technology Center, 1555 South Harding Street, Indianapolis, Indiana 46225, following an inspection conducted from October 17-21, 2022. The inspection was of a manufacturer of parenteral operations.

The inspection revealed three observations related to deficiencies in aseptic technique and processing areas.

Observation 1 noted deficient aseptic technique in drug product filling operations. Specifically, production operators conducted Grade A RABS setup over unprotected sterile surfaces, handled unprotected sterile components using sanitized instead of protective wrapped components, and interchangeably handled common items during Grade A RABS setup interventions. Additionally, operators did not always use unsoiled wipe surfaces for sanitizing, and did not consistently adhere to the firm's General Aseptic Practices and Techniques for Parenteral Filling and Manufacturing Operations document (001-005056/PRD-95744, version: 27.0).

Observation 2 identified deficiencies in aseptic processing areas regarding personnel monitoring following critical RABS activities. Production operators sanitized directly or indirectly with sanitizer wipes prior to monitoring for critical RABS interventions.

Observation 3 stated that the firm's efficacy study (Summary of Agent Efficacy Studies to Support Indy Parenteral Manufacturing Site-2018, Document SAV 000 099