483
Smart World LLCFDA 483 - Smart World LLC - June 05, 2026
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An FDA inspection of Smart World LLC, a contract sterilizer in Fremont, CA, revealed two significant observations. The firm failed to ensure that only validated part numbers were processed during sterilization services, and its risk management processes were inadequately documented, specifically regarding the consideration of severity of harm in risk level calculations.
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ID · 36a1e8ff-68db-4770-9051-a2cedb4ac827