# FDA 483 - Smart World LLC - June 03, 2025

Source: https://www.keypedia.com/records/483/smart-world-llc/fe3d4094-abd8-459d-885c-192c9e1d33de

> FDA 483 for Smart World LLC on June 03, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smart World LLC
- Inspection Date: 2025-06-03
- Product Type: other
- Office Name: San Francisco District Office
- Summary: Smart World LLC dba Steri-Tek, a contract sterilizer in Fremont, CA, was cited for significant quality system and facility maintenance deficiencies during an FDA inspection. Observations included a lack of written procedures for the quality control unit, such as defining roles and responsibilities and handling recalls, leading to product release without proper Quality approval. Additionally, the facility's buildings were not maintained in good repair, with issues like an unsealed receiving door and pest control bait boxes surrounded by debris.

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

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