U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Marukai Foods Co., Inc. (Takasu Factory) - 07/14/2014
  1. Warning Letters

WARNING LETTER

Marukai Foods Co., Inc. (Takasu Factory)


Recipient:
Marukai Foods Co., Inc. (Takasu Factory)


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

JUL 14, 2014

WARNING LETTER

VIA EXPRESS DELIVERY
 

Mr. Mikazuki Sumida, Owner/Representative Director
Marukai Foods Co., Inc.
4840-12 Takasu-cho
Onomichi-city,
Hiroshima Prefecture
Japan 7290141
 

Re:433887
 

Dear Mr. Sumida:

The United States Food and Drug Administration (FDA) inspected your facility, Marukai Foods Co., Inc. located in Onornichi-city, Hiroshima Prefecture Japan on February 19, 2014 through February 20, 2014. The inspection was conducted to determine compliance with the Federal, Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food that you ship to the United States. Based on our review, we have concluded that your Small Young Sardine (4.23 oz.), Small Young Sardine (8.82 oz.), and Dried Sardine (5 oz.) products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and these regulations through links in FDA's home page at www.fda.gov.

1. Your Small Young Sardine (4.23 oz.), Small Young Sardine (8.82 oz.), and Dried Sardine (5 oz.) products are misbranded within the meaning of Section 403 (b) [21 U.S.C. § 343(b)] of the Act in that they are offered for sale under the name "sardine," but are in fact "anchovies."

2. Your Small Young Sardine (4.23 oz.), Small Young Sardine (8.82 oz.) and Dried Sardine (5 oz.), products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because they contain information in two languages but does not repeat all the required label information in both languages. For example, the Nutrition Facts information must be declared in both, Japanese and English as required by 21 CFR 101.15(c)(2).

In accordance with 21 CFR 1 01.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

3. Your Small Young Sardine (4.23 oz.), Small Young Sardine (8.82 oz.), and Dried Sardine (5 oz.) products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format. For example:

• The serving sizes for your Small Young Sardine (4.23 oz.), Small Young Sardine (8.82 oz.), and Dried Sardine (5 oz.) are not expressed as "an amount customarily consumed" that is appropriate to the food as defined within 21 CFR 101.12. The Reference Amount Customarily Consumed (RACC) for dried fish, including dried anchovies or dried sardines, is 30 grams. A sample serving size statement is "_ piece(s) (_g)."

• The Dried Sardine (5 oz.) label fails to declare the Trans fat content in accordance with 21 CFR 101.9(c)(2)(ii).

• The Dried Sardine (5 oz.) label fails to declare the saturated fat content as required by 21 CFR 101.9(c)(2)(i).

• The Dried Sardine (5 oz.) label fails to declare the dietary fiber content as required by 21 CFR 101.9(c)(6)(i).

• The Dried Sardines 5 oz. label fails to declare the sugar content as required by 21 CFR 101.9(c)(6)(ii).

This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products or injunction.

We also note, the statement of the place of business must include the street address, unless it is shown in a current city directory or telephone directory.

We request that you notify this office in writing, within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.

You should direct your written reply to: Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions regarding this letter you may contact Ms. Young via email at dehlia.young@fda.hhs.gov.
 

Sincerely,
/S/
WilliamA. Correll, Jr.
Acting Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

Close Out Letter