Modern Macaroni Co Ltd 9/2/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
UNITED PARCEL SERVICE
September 2, 2014
Mr. Darrell E. Siu
President and Owner
Modern Macaroni Co. Ltd.
1708 Mary Street
Honolulu, Hawaii 96819
Dear Mr. Siu:
We inspected your processing facility, located at 1708 Mary Street, Honolulu, Hawaii 96819 on April 16-28, 2014. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your products, Hula Brand Hana Ebi (artificially colored shrimp flakes) and Hula Brand Fun Chow noodles, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the FDA regulations, including the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
In addition, our investigator collected a sample of your green Hula Brand Hana Ebi (artificially colored shrimp flakes) for sulfite and color analysis. We have reviewed our analytical results and your Hula Brand Hana Ebi label and find that the product is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
Your significant violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur. You must also have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However your firm does not have a HACCP plan for your Hula Brand Hana Ebi to control the food safety hazards of allergens (crustacean shellfish), or food and color additives (Sulfiting agents and FD&C Yellow #5). Please refer to Chapter 19 of the Fish and Fishery Products Hazards and Control Guidance (The Guide), Fourth Edition for additional information and guidance on hazard control strategies.
a. Based on our analytical results from the sample collected by our investigator of your Hula Brand Hana Ebi, the product contains 208 ppm of sodium bisulfite. Your bulk dried shrimp supplier’s specification sheet and labeling indicates that the product may contain sodium bisulfite, for which you failed to identify and control through proper labeling of your finished product.
b. During your process of Hula Brand Hana Ebi, you add FD&C Yellow No. 5. While we acknowledge that your finished product label declares “Yellow #5”, you do not have a HACCP Plan to control the hazard that consumers sensitive to FD&C Yellow No. 5 may consume the product.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, as required by 21CFR 123.11(b)(2) or the maintenance of hand washing and toilet facilities, as required by 21CFR 123.11 (b)(4), with sufficient frequency as evidenced by the following:
a. The grinder used to process your Hula Brand Hana Ebi was observed caked with what appeared to be both red and green colored shrimp flakes. An employee told our investigator it had last been used three days prior to this observation. Your current level of cleaning is not adequate to prevent microbial growth and cross contamination of the products you process in this grinder. This includes possible contamination with artificial colors not declared on the finished product label.
b. The trays you use to hold and dry your in-process Hula Brand Hana Ebi are constructed of worn wood material which cannot be easily cleaned. An employee also told our investigator that you do not clean or sanitize the trays before or after use. The materials and practices used in this process may lead to contamination of your products.
c. Our investigator observed that there was no warm water available in the employee restroom for your employees to adequately wash their hands.
Current Good Manufacturing Practice (CGMP):
1. As required by 21 CFR 110.40(a), equipment and utensils shall be so designed as to be adequately cleanable, and shall be properly maintained. Additionally, per 21 CFR 110.40(c), equipment that is in the food handling area that does not come into contact with food shall be so constructed that it can be kept in a clean condition.
However, our investigator took photographs which show in process Hula Brand Fun Chow noodles in direct contact with wooden hanging rods and drying trays which appear heavily worn and not easily cleanable. Additionally, in the small outside room where you dry your Hula Brand Fun Chow noodles, the floors, walls, metal fans and wooden racks were seen heavily worn and coated in dust and debris. The condition of this room is such that dust and debris may be blown into the air by the fans, then settle onto the drying noodles.
1. Your Hula Brand Hana Ebi (red) shrimp flakes and Hula Brand Hana Ebi (green) shrimp flakes products are misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), because the products bear or contain an artificial flavoring, coloring, or chemical preservative, but fail to bear labeling stating that fact. For example:
- Your Hula Brand Hana Ebi (red) shrimp flakes and Hula Brand Hana Ebi (green) shrimp flakes products are manufactured with FD&C Red No. 40; however, the finished product label fails to declare the presence of this color additive. Under 21 CFR 101.22(k)(l), certified colors must be declared by the name of the color additive listed in the applicable regulation in Part 74 or Part 82 of this chapter. The common or usual name may be abbreviated to omit the “FD&C” prefix and the term “No.” (e.g., Yellow 5).
- Your Hula Brand Hana Ebi (red) shrimp flakes and Hula Brand Hana Ebi (green) shrimp flakes products are manufactured using sodium bisulfite; however, the finished product labels fail to declare the presence of this chemical preservative. In accordance with 21 CFR 101.22, the declaration of the chemical preservative must include the specific name of the ingredient followed by the function.
2. Your Hula Brand Hana Ebi (red) shrimp flakes and Hula Brand Hana Ebi (green) shrimp flakes products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product is fabricated from two or more ingredients and each ingredient is not declared on the labels, as required by 21 CFR 101.4. For example, the labels fail to declare the presence of sulfites as an ingredient. Any sulfiting agent that has been added to any food or to any ingredient in any food in amounts of 10 ppm or more must be declared as an ingredient on the label (see 21 CFR 101.100(a)(4) and 21 CFR 101.4(a)(1)). As noted above, your Hula Brand Hana Ebi shrimp flake products contain 208 ppm of sodium bisulfite. Additionally, your products are manufactured using the ingredient ground shrimp, which is a multicomponent ingredient in that it contains two or more ingredients; however, you fail to list all sub-ingredients on your finished product labels.
According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
We acknowledge that on June 4th, 2014, you told our district Recall Coordinator that you would send a letter and corrective label to your customers who purchased the Hula Brand Hana Ebi, advising them not to sell the product without the added label which stated that the product contained sulfites. As of today, we have not received any documentation or verification of your actions. Thus, we will verify the adequacy of your corrective actions during our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring you operate in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR 110) and food labeling regulation (21 CR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective action may result in FDA taking regulatory action such a seizure or injunction without further notice.
We note, your Hula Brand Hana Ebi (red) shrimp flakes and Hula Brand Hana Ebi (green) shrimp flakes product labels fail to declare the serving size in terms of the common household measure as specified in 21 CFR101.9(b)(5). The RACC for seasoning/spice is 1/4 teaspoon or 0.5 g if not measurable by teaspoon (21 CFR 101.12 Table 2, Miscellaneous Category, Spices herbs (other than dietary supplements)). A sample serving size statement is "1/4 tsp (_ g)"; _ pieces ( _ g if not measurable by teaspoons) for your product.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. 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 costs.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and stat when you will correct any remaining violation.
Please send your reply to the Food and Drug Administration, Attention:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
Refer to the Unique Identification Number CMS case #430244 when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
Kathleen M. Lewis, J.D.