# FDA 483 - Smart World LLC - June 05, 2026

Source: https://www.keypedia.com/records/483/smart-world-llc/36a1e8ff-68db-4770-9051-a2cedb4ac827

> FDA 483 for Smart World LLC on June 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smart World LLC
- Inspection Date: 2026-06-05
- Product Type: device
- Office Name: San Francisco District Office
- Summary: 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.

## Related Documents

- [EIR - 2019-04-10](https://www.keypedia.com/records/eir/smart-world-llc/86be8cdf-3fe0-44b9-9ed0-2aac7b1f86e4)
- [EIR - 2020-03-10](https://www.keypedia.com/records/eir/smart-world-llc/48e17f19-85c0-4214-99b0-7c3b22cc3e35)
- [483 - 2025-06-03](https://www.keypedia.com/records/483/smart-world-llc/fe3d4094-abd8-459d-885c-192c9e1d33de)

## Related Officers

- [Sasha L. Eckstein](https://www.keypedia.com/people/sasha-l-eckstein/97a787c8-76da-481f-b18c-8f9d5f0131e1)
- [Jordan I. Abel](https://www.keypedia.com/people/jordan-i-abel/9cdc8877-ab20-4c0c-a17e-a8534d4f13f2)

Company: https://www.keypedia.com/companies/smart-world-llc/58245a58-1141-4b8e-bdea-df100fec1aef

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df