# FDA 483 - Eli Lilly Italia SPA - February 10, 2023

Source: https://www.globalkeysolutions.net/records/483/eli-lilly-italia-spa/a9c4ffac-3570-489a-89e9-39b878c32958

> FDA 483 for Eli Lilly Italia SPA on February 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly Italia SPA
- Inspection Date: 2023-02-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Eli Lilly Italia S.p.A. in Sesto Fiorentino, Italy, was issued a Form FDA 483 with two observations following an inspection from February 2-10, 2023. The inspection revealed issues with equipment design leading to black particle generation and a lack of comprehensive quality risk assessment. Additionally, the firm failed to establish or follow adequate written procedures for production and process controls, impacting aseptic process simulation, revalidation, system qualification, filter drying, and equipment maintenance, raising significant concerns about product quality and control.

## Related Officers

- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/eli-lilly-italia-spa/fe932949-0f6d-4e17-8349-73b2b9e19e43

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd