# FDA 483 - DEMOBREAD INC dba FIRST HARVEST - February 07, 2025

Source: https://www.keypedia.com/records/483/demobread-inc-dba-first-harvest/563084e3-6b95-4ea7-b2f6-5f4240b1f5bf

> FDA 483 for DEMOBREAD INC dba FIRST HARVEST on February 07, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DEMOBREAD INC dba FIRST HARVEST
- Inspection Date: 2025-02-07
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: This FDA Form 483 was issued to DEMOBREAD INC dba FIRST HARVEST in Boca Raton, FL, following an inspection of their Foreign Supplier Verification Program. The inspection revealed significant deficiencies, primarily a lack of written procedures for hazard analysis, foreign supplier evaluation, and foreign supplier approval and verification activities for imported food products. These observations indicate a failure to establish and implement a compliant FSVP.

## Related Officers

- [Robert B. Hurley](https://www.keypedia.com/people/robert-b-hurley/526e6e16-c6b3-45b2-b62e-2f64abe97fae)
- [Laura M. Lopez](https://www.keypedia.com/people/laura-m-lopez/5c971465-15dc-4971-a1ac-1edfc3cb5ab7)

Company: https://www.keypedia.com/companies/demobread-inc-dba-first-harvest/b1ff3b27-98df-441c-b912-c329e556e648

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6