FDA 483 - FRUSELVA USA - August 29, 2024

The FDA issued a Form 483 to Raney ret AASELA SI Logistics following an inspection of its Foreign Supplier Verification Program (FSVP) conducted from July 25 to August 29, 2024. The observations highlight significant deficiencies in the company's compliance with regulations for imported food, particularly concerning Baby Food Squash, Apple Sauce Strawberry, and Apple Sauce Strawberry with Banana.

Key violations primarily revolve around a lack of documented procedures and assessments. The company failed to document its review and assessment of hazard analyses conducted by other entities, and confirm these were performed by qualified individuals. Crucially, for low-acid canned foods, there was no verification documentation that products were produced according to regulatory standards.

Further issues included insufficient documentation regarding the evaluation, approval, and reevaluation of foreign supplier performance and the associated food risks. Raney ret AASELA SI Logistics also did not provide adequate evidence that individuals conducting supplier evaluations were qualified. Moreover, the firm failed to conduct and document essential supplier verification activities before importing food into the U.S., did not follow its written procedures for importing from approved suppliers, and most significantly, did not develop an FSVP for certain products. These observations indicate a systemic failure to meet regulatory requirements for ensuring the safety of imported food, necessitating immediate corrective actions by the firm.