FDA 483 - FRUSELVA USA LLC - August 29, 2024

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.