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# Lilly Issued 483 on Aseptic Operations
- URL: https://www.fdaweb.com/lilly-issued-483-on-aseptic-operations/
- Published: 2023-05-01T12:00:00.000Z
- Updated: 2026-09-14T18:28:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154334

FDA has issued Eli Lilly a three-item [Form FDA-483](https://www.fda.gov/media/167686/download?ref=fdaweb.com) after aseptic processing deficiencies were identified during a 10/17-21/2022 inspection at the Lilly Technology Center in Indianapolis, IN. The heavily redacted inspection form cited the firm’s “deficient” aseptic technique associated with a drug product filling operation. It also cited production operators over their handling of unprotected sterile components.

Additionally, FDA investigators took issue over Lilly’s aseptic processing areas for two products due to an inadequate process for personnel monitoring. And, they said a company study does not adequately support a certain sanitization procedure.