FDA 483 - VOLAC INC - February 04, 2025

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.