# FDA 483 - Eli Lilly & Company - October 17, 2022

Source: https://www.keypedia.com/records/483/eli-lilly-company/0122f6aa-1103-4f80-a3f6-6abe81842b50

> FDA 483 for Eli Lilly & Company on October 17, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Eli Lilly & Company
- Inspection Date: 2022-10-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Eli Lilly and Company in Indianapolis, Indiana, received three observations during an FDA inspection concerning deficiencies in their manufacturing processes. The observations highlight issues with aseptic technique during drug product filling operations, including improper handling of sterile components and inadequate sanitization practices. Additionally, the firm's disinfection efficacy study was found to be insufficient in supporting observed sanitization procedures.

## Related Documents

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

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Mercy Oyugi](https://www.keypedia.com/people/mercy-oyugi/9da8ebdc-a4c6-4666-9096-9a17f4edcf6c)
- [Nailing Zhang](https://www.keypedia.com/people/nailing-zhang/d3814d08-b799-4de1-b901-1b90da0e0178)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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

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