FDA 483 - Eli Lilly & Company - June 16, 2023

This FDA Form 483 was issued to Eli Lilly and Company, a drug product manufacturer located at Lilly Corporate Center, Indianapolis, Indiana 46285. The inspection was conducted from June 8, 2023, to June 16, 2023, and the report was issued to Mr. Matt Edwards, Sr. Vice President - Indianapolis Parenteral Operations.

Three observations were noted:

1. **Deficient Production and Process Controls:** A written procedure (PRD-96285, 'Filler', v33.0) for sanitization was not followed. Specifically, a table moved into a critical Grade A space had only its top equipment contact surface sanitized in Grade B space, rather than the complete portion as required. Additionally, an environmental monitoring device was transitioned from Grade B to Grade A space without sanitization. This impacts the assurance of drug product identity, strength, quality, and purity.

2. **Deficient Laboratory Procedure for Sample Traceability:** The procedure PRD-95676, 'Sample Handling and Chain of Custody', v20.0, states that samples should be disposed of timely after verification/release. However, extra test samples acquired from manufacturing were not reconciled to the batch, and their destruction process was not documented, compromising test sample traceability.

3. **Inadequate Equipment Validation:** Equipment validation for the (b)(4) units (6