FDA 483 - Able Sales Company, Inc. - November 01, 2022

Able Sales Company, Inc., a food warehouse and juice importer in Catano, PR, was cited for significant deficiencies in its juice HACCP import verification procedures. The firm failed to implement affirmative steps to ensure imported juice complied with regulations, including inadequate product specifications, insufficient pathogen testing for products like orange, pineapple, guava, and soursop pulps, and unsigned or outdated HACCP plans. Additionally, the firm lacked qualified personnel to review critical control point, corrective action, and calibration records for juice processing.