Place Category: Bakeshops
Filipino bakery selling Pandesal, Taro Bread, “Balintawak” and Spanish Rolls in the Kalihi area of Honolulu…
In December 2016, the U.S. Food & Drug Administration sent a warning letter to Regalo’s because of the results of inspections earlier that year.
The FDA investigator documented serious violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations cause the foods manufactured at Regalo’s facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Additionally, FDA investigators found that Regalo’s products are not labeled in accordance with FDA’s regulations, Food Labeling, Title 21 Code of Federal Regulations Part 101 [21 CFR Part 101]. These violations cause the products to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You can find the Act and its implementing regulations at www.fda.gov.
The letter was addressed to Ms. Ruby Ho, President of Regalo’s Favorite of Hawaii, Inc. located at 421 North King Street, Honolulu, HI 96817
Case number 508259
Net weight 14 ounces (398 grams)
UPC 0 782532 309195
Bar code 0782532309195
Address: 421 N King Street
United StatesPhone: (808) 524-8421