Inspection Record

Eli Lilly and Company — FDA 483 Findings

US FDAInspected 2023-06-16Published 2025-03-24 3 findingsEquipment and facilityProcess validationLaboratory and QC controls

Inspectors Wayne Seifert · Debara Reese · Melina Rodriguez UptonThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

An equipment validation is inadequate in support ofmanufacture.

2Process validation

A written procedure is not followed or is deficient for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity that they purport or are represented to possess.

3Laboratory and QC controls

A laboratory procedure, practice is deficient in support oftest sample traceability.

About this record

Extracted automatically from the document US FDA published on 2025-03-24. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2015-07-11 · US FDA · 33 findings2021-03-16 · US FDA · 7 findings
Eli Lilly and Company findings history — including this company's other documents US FDA documents, 2025 Go to Findings search