483
Lifecore Biomedical LLCLifecore Biomedical LLC – FDA 483, Mar 12, 2025
Record Details
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.
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ID · 62a3575d-9a57-49b0-b1ba-cf30d3f7c433
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