# FDA 483 - Lifecore Biomedical LLC - March 12, 2025

Source: https://www.globalkeysolutions.net/records/483/lifecore-biomedical-llc/62a3575d-9a57-49b0-b1ba-cf30d3f7c433

> FDA 483 for Lifecore Biomedical LLC on March 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lifecore Biomedical LLC
- Inspection Date: 2025-03-12
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Lifecore Biomedical, LLC in Chaska, MN, from March 3-12, 2025, revealed two significant observations. The firm failed to adequately clean and maintain its water for injection (WFI) system and lacked a scientifically sound process to monitor it after maintenance. Additionally, the company did not consistently follow its written stability testing program, resulting in late and sometimes unjustified stability sample testing.

## Related Documents

- [EIR - 2015-11-20](https://www.globalkeysolutions.net/records/eir/lifecore-biomedical-llc/6955ab63-813f-4568-834c-7671d1ef9e9d)
- [483 - 2017-03-02](https://www.globalkeysolutions.net/records/483/lifecore-biomedical-llc/795ce433-e7ef-4c17-89fa-71a2a5a05dc1)
- [483 - 2019-02-26](https://www.globalkeysolutions.net/records/483/lifecore-biomedical-llc/6cd021a8-2980-47aa-842e-6646a670f5ee)
- [483 - 2021-01-21](https://www.globalkeysolutions.net/records/483/lifecore-biomedical-llc/354142ff-c6a7-4835-8bbb-40ee39777c2e)

## Related Officers

- [Tyler M. Peterson](https://www.globalkeysolutions.net/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)
- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/lifecore-biomedical-llc/8ff9e05e-cb2b-42d1-971d-9736e5f0e73c

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d