FDA 483 - RW Garcia Co. Inc. - August 05, 2022

An FDA inspection of RW Garcia Co. Inc. in Lincolnton, NC, revealed significant deficiencies in their allergen preventive controls. The firm failed to adequately identify and control allergen hazards, maintain proper written procedures for allergen cleaning, and effectively implement and verify these procedures. This led to potential cross-contamination risks due to product residue remaining on equipment after changeover.