# FDA 483 - VOLAC INC - February 04, 2025

Source: https://www.keypedia.com/records/483/volac-inc/0471a1f5-96d8-4f6b-a859-a5feceff47d2

> FDA 483 for VOLAC INC on February 04, 2025. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: VOLAC INC
- Inspection Date: 2025-02-04
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: VOLAC INC, located in Pace, FL, underwent an FDA inspection of its Foreign Supplier Verification Program (FSVP). The inspection revealed two significant issues: the firm failed to develop an FSVP for certain imported products and did not document its review and assessment of a hazard analysis conducted by another entity. These observations indicate a lack of compliance with FSVP requirements for imported goods.

## Related Officers

- [Sheirly J. Reyes](https://www.keypedia.com/people/sheirly-j-reyes/4b0053ce-da1e-4594-841d-5fcf419a6f8f)

Company: https://www.keypedia.com/companies/volac-inc/8a8e7936-4112-4a36-9f5b-ba253632e6cf

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