483
Innovize IncInnovize Inc – FDA 483, Mar 26, 2025
Record Details
An FDA inspection of Innovize LLC, a contract manufacturer in St Paul, MN, revealed two significant observations. The firm failed to include required information, specifically dates of investigation, in complaint records and its procedures did not mandate this documentation. Additionally, documents were not approved by designated individuals prior to issuance, as demonstrated by the use of an investigation summary form without an approved procedure.
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ID · 4ed6f523-1a82-4099-84a7-e6de9c34c259
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