FDA WARNING_LETTER - Regalo's Favorite of Hawaii Inc. - September 06, 2016

On December 28, 2016, the FDA issued a Warning Letter to Regalo's Favorite of Hawaii, Inc., following an inspection of their bakery facility from August 29-31 and September 6, 2016. The inspection revealed serious violations of current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110), causing their food products to be adulterated under section 402(a)(4) of the Act due to insanitary conditions. Additionally, products were found to be misbranded under section 403 of the Act due to non-compliance with Food Labeling regulations (21 CFR Part 101).

Key adulteration violations included failure to maintain equipment in an acceptable condition through cleaning and sanitizing (21 CFR 110.80(b)(1)), such as product residue on mixer bowls, bread dough roller belts, and pans stored in soiled boxes, and a dirty knife. The firm also failed to maintain equipment to facilitate cleaning, specifically a wood dough table with deep cracks and accumulated debris (21 CFR 110.40(a)). Furthermore, inadequate pest protection was observed, with an exterior door left open during processing and ingredients stored outdoors without screening (21 CFR 110.20(b)(7)).

Significant misbranding violations included the Spanish Roll product failing to declare major food allergens (eggs, wheat