1Equipment and facility
An equipment validation is inadequate in support ofmanufacture.
Inspection Record
Eli Lilly and Company — FDA 483 Findings
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
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.
