VOLAC INCFebruary 4, 2025

FDA 483 - VOLAC INC - February 04, 2025

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Record Details

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.

Company: VOLAC INC
Inspection Date: February 4, 2025
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
Person: Sheirly J. Reyes

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ID · 0471a1f5-96d8-4f6b-a859-a5feceff47d2