# FDA 483 - Eli Lilly & Company - March 16, 2021

Source: https://www.globalkeysolutions.net/records/483/eli-lilly-company/9fdf10fc-bc85-478c-affd-9279176c5cb7

> FDA 483 for Eli Lilly & Company on March 16, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Eli Lilly & Company
- Inspection Date: 2021-03-16
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: This FDA Form 483 issued to Eli Lilly and Company in Indianapolis, IN, details critical deficiencies in their sterile human drug manufacturing. Observations include inadequate environmental monitoring in aseptic processing areas, failures in investigating discrepancies and batch failures, and a lack of appropriate procedures to prevent microbiological contamination. Further issues were identified in visual inspection training, the drug product stability program, and component sampling.

## Related Documents

- [483 - 2023-10-06](https://www.globalkeysolutions.net/records/483/eli-lilly-company/d4bd2e3f-d3e2-4c57-a46e-f2bedba3c548)
- [EIR - 2023-05-18](https://www.globalkeysolutions.net/records/eir/eli-lilly-company/15f9ed35-a475-4557-b1f2-753ea60f17a2)
- [EIR - 2020-01-17](https://www.globalkeysolutions.net/records/eir/eli-lilly-company/00535940-b628-4bcd-aa01-17eb95be770e)
- [483 - 2023-06-16](https://www.globalkeysolutions.net/records/483/eli-lilly-company/ad3d5c22-c165-4f63-91cc-163c31217be2)
- [483 - 2025-05-20](https://www.globalkeysolutions.net/records/483/eli-lilly-company/885fecd9-f6cd-48fd-90eb-66d12ec35d07)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Investigator](https://www.globalkeysolutions.net/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)
- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0