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483
•Smart World LLC•June 5, 2026

FDA 483 - Smart World LLC - June 05, 2026

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Record Details

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.

Company
Smart World LLC
Inspection Date
June 5, 2026
Product Type
Device
Office
San Francisco District Office
People
  • Sasha L. Eckstein
  • Jordan I. Abel
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ID · 36a1e8ff-68db-4770-9051-a2cedb4ac827

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