# FDA 483 - Lattice Inc - May 22, 2025

Source: https://www.keypedia.com/records/483/lattice-inc/32200d24-cd21-427c-849b-d4ec520552f9

> FDA 483 for Lattice Inc on May 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lattice Inc
- Inspection Date: 2025-05-22
- Product Type: device
- Office Name: FDA District Office — Chicago, Illinois
- Summary: Lattice Inc, a software manufacturer in Wheaton, IL, was cited for seven significant quality system deficiencies during an FDA inspection. Key issues include inadequate risk analysis for its MediCopia Transfusion device, deficiencies in corrective and preventive action procedures, and a lack of proper unique device identification (UDI) on device labels. Several observations were repeats from previous inspections, indicating persistent non-compliance.

## Related Documents

- [483 - 2020-01-17](https://www.keypedia.com/records/483/lattice-inc/46249901-a873-4ca1-9276-3c2e4ae10564)
- [483 - 2025-05-22](https://www.keypedia.com/records/483/lattice-inc/25b951e2-4732-4935-8d96-6996f957c91e)

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)
- [FDA_PERSONNEL](https://www.keypedia.com/people/zoey-a-trombley/cb7ac4dd-bc47-4b51-8fef-a485b122c921)

Company: https://www.keypedia.com/companies/lattice-inc/300ca91e-9175-4b16-b42b-66d755e58952

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65