# FDA 483 - Eli Lilly & Company - May 20, 2025

Source: https://www.globalkeysolutions.net/records/483/eli-lilly-company/885fecd9-f6cd-48fd-90eb-66d12ec35d07

> FDA 483 for Eli Lilly & Company on May 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly & Company
- Inspection Date: 2025-05-20
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Eli Lilly & Company in Indianapolis, IN, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in manufacturing process controls, including inadequate automated visual inspection qualification and aseptic processing validation. Other issues included a failure to validate supplier test results for critical components, insufficient cleaning and maintenance procedures, and incomplete quality control unit procedures regarding complaint investigations.

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Company: https://www.globalkeysolutions.net/companies/eli-lilly-company/fc56eed7-d261-4de3-865e-c2aa54162adf

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03