- Regalo's Favorite of Hawaii Inc.
- Issuing Office:
- Los Angeles District Office
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1431 Harbor Bay Parkway
Alameda, CA 94502-7070
December 28, 2016
Ms. Ruby Ho, President
Regalo’s Favorite of Hawaii, Inc.
421 N. King Street
Honolulu, HI 96817
Dear Ms. Ruby Ho:
The U.S. Food and Drug Administration (FDA) inspected your bakery facility, located at 421 N. King Street, Honolulu, HI, between August 29-31, and September 06, 2016. During the inspection, 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 your 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, our investigators found that your 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
You significant violations are as follows:
1. Your firm failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1). Specifically our investigator observed:
a. A bowl, not cleaned and sanitized before use, was observed with product residue on the inner food contact surface and on the blade of the mixer. This mixer bowl and blade is used to make dough.
b. A bread dough roller belt, not cleaned and sanitized before use, was observed with product residue and dark stains.
c. Pans not cleaned and sanitized before use, stored in worn and soiled cardboard boxed. Cardboard boxes are not cleanable and sit directly on the floor. The pans are used to bake bread.
d. A knife, not cleaned and sanitized before use, is stored on a dusty file cabinet under a microwave. This knife was observed being used to cut bread dough.
2. Your firm failed to maintain equipment so as to facilitate cleaning of the equipment, as required by 21 CFR Part 110.40(a). Specifically our investigators observed after cleaning, a wood table used to prepare dough that has deep cracks and crevices with accumulated debris that is not easily cleaned and sanitized.
3. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR Part 110.20(b)(7). Specifically our investigators observed:
a. A door that leads to the exterior of the facility was left open during processing of bread.
b. Bags of flour and other ingredients used to process your finished product stored outdoors without screening to protect against pests.
1. Your Spanish Roll product is misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare the major food allergens eggs, wheat, and milk, as required by section 403(w)(1) of the Act. Specifically, your Spanish Roll recipe includes the ingredients wheat flour, milk, butter, and eggs. The label for this product lists “flour,” but fails to declare wheat, lists “butter,” but not milk, and fails to list eggs.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
- The word “Contains;” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
- The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
We acknowledge that on September 01, 2016, a recall was initiated and ongoing with our district Recall Coordinator and an issued press release. In addition, you acknowledged that you would correct the labels immediately. However, the adequacy of your correction could not be evaluated as the revised product labels were not forwarded to our District office.
2. Your Spanish Roll product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the product bears or contains a chemical preservative but does not bear labeling stating that fact. Specifically, according to your management the product contains the chemical preservatives sodium benzoate and propylparaben, but fails to bear labeling stating that fact, in accordance with 21 CFR 101.22(j).
In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative(s) is added shall bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g. “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.
3. Your Taro Bread, Spanish Roll, Pandesal Enriched Rolls, and Balintawak products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the labels, as required under 21 CFR 101.4. For example:
a. According to your Spanish Roll recipe, the ingredients water, milk, eggs, and vanilla are used in the product. However, the label for this product fails to list these ingredients, in accordance with 21 CFR 101.4(b)(2).
Further, your Spanish Roll label lists “Enriched Flour” and “shortening” as ingredients.
i. “Enriched Flour” is a multicomponent ingredient in that it contains two or more ingredients; however, you fail to list all of its sub-ingredients on your finished product label (21 CFR 101.4(b)(2)).
ii. “Shortening” is not the common or usual name of the shortening ingredient. 21 CFR 101.4(b)(14), requires that each individual fat and or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g., "beef fat," "cottonseed oil") in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as "shortening" or "blend of oils," the blank to be filled in with the word "vegetable," "animal," "marine," or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., "vegetable oil shortening (soybean and cottonseed oil)." Your Spanish Roll product declares “shortening” as an ingredient but fails to list the specific components of the shortening ingredient. The term “shortening," on its own, is not a proper common or usual name because it does not list the common or usual name of each component fat or oil, as required by 21 CFR 101.4(b)(14).
b. Your Balintawak label lists the ingredient, “bread crumbs,” but fails to list the bread crumb sub-ingredients, 21 CFR 101.4(b)(2).
c. Your Taro Bread, Spanish Roll, Pandesal Enriched Rolls, and Balintawak labels list “S-500” and/or “dough conditioner” as ingredients. “S-500” and “Dough conditioner” are not the common or usual name of food ingredients, 21 CFR 101.4(a)(1).
d. The ingredient “fungalamylase” declared in the ingredient list on the Pandesal Enriched Rolls product label should be two words, “fungal amylase.”
e. The labels for the Taro Bread, Spanish Roll, Pandesal Enriched Rolls, and Balintawak declare “Enriched Flour” which is a standardized food (21 CFR 137.165) that must contain folic acid. However, folic acid is not declared as one of the sub-ingredients of “enriched flour.”
4. Your Taro Bread product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product label fails to include the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
5. Your Pandesal (Enriched Rolls) product is misbranded within the meaning of section 403(g) of the Act [21 U.S.C. § 343(g)] in that it is represented as the standardized food Enriched rolls (21 CFR 136.115); however, it does not meet the requirements under the standard because folic acid, a required nutrient, is not declared in the ingredient list.
6. Your Balintawak product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the label does not include an appropriate statement of identity as required by 21 CFR 101.3. If this is intended to be a fanciful term, we would not object as long as an appropriate statement of identity is included.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, and the Current Good Manufacturing Practice regulation (21 CFR Part 110).
You should take prompt action to correct these violations and to establish procedures whereby such violations do no recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to an injunction.
We also offer you the following comments:
- The Pandesal Enriched Rolls label lists a net content of, “NET WT. 40 oz. (1132 g.).” However, the net weight statement fails to also include the net weight in pounds and ounces (e.g., 2 lbs 8 oz, or alternatively, 2.5 lbs or 2 ½ lbs) as required by 21 CFR 101.7(j) and (m) for dual declaration.
- The Balintawak label lists a net content of, “NET WT. 16 OZ,” but fails to also include the net weight in pounds (i.e., 1 lb.) as required by 21 CFR 101.7(j) and (m) for dual declaration.
- The Spanish Roll recipe states “Anpan;” however, it is unclear whether this is an ingredient in this product. If so, additional ingredients are undeclared on the product label.
Section 743 of the Act [21 U.S.C § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these violations. You may wish to include in your response documentation such as labels, and photographs of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
Please send your reply to the Food and Drug Administration, Attention:
Lawton W. Lum,
Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case number 508259
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737.
Kathleen M. Lewis, JD