# FDA 483 - FRUSELVA USA LLC - August 29, 2024

Source: https://www.keypedia.com/records/483/fruselva-usa-llc/0a7fca2d-b8f0-495b-a035-0094752cafd5

> FDA 483 for FRUSELVA USA LLC on August 29, 2024. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: FRUSELVA USA LLC
- Inspection Date: 2024-08-29
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: FRUSELVA USA, located in Miami, underwent an FDA inspection of its Foreign Supplier Verification Program (FSVP). The inspection revealed ten significant deficiencies primarily related to inadequate documentation of hazard analyses, foreign supplier evaluations, and verification activities for imported baby food and apple sauce products. The firm also failed to develop an FSVP for one of its imported products, indicating a systemic lack of compliance with FSVP requirements.

## Related Officers

- [Derick Huertas Alvarez](https://www.keypedia.com/people/derick-huertas-alvarez/f89f723d-8903-4a75-9dd6-19a7d1ddd8d1)

Company: https://www.keypedia.com/companies/fruselva-usa-llc/ede6c84e-e493-4016-b199-4bcadb9726ee

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