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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

New Japan International Inc. 13-Nov-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food & Drug Administration
19900 MacArthur Blvd., Ste 300
Irvine, California 92612-2445
Telephone (949) 798-7600

Certified Mail
RETURN RECEIPT REQUESTED
November 13, 2001
WARNING LETTER WL-102-02

Yen K. Trim, Owner
New Japan International Inc.
4560 Worth Street
Los Angeles, CA 90063

Dear Ms. Trieu,

The Food and Drug Administration (FDA) has information which shows your firm violated the Federal Food, Drug, and Cosmetic Act and referenced provisions of the United States Code (U.S.C).

Entry Number

Product

Invoiced Quantity

Arrival Date

T76-012368-1/3/1

Frozen Spring Roll

[redacted] cartons

4/28/01

Frozen. Spring Roll offered for import into the United States by your firm was sampled by FDA and detained m June 1, 2001 since the article was found to be adulterated with Salmonella, a poisonous ad deleterious substance which may render it injurious to health with the meaning the Food, Drug & Cosmetic Act 402(a)(l).

This article was Refused Admission on May 2, 2001. Arrangements were made to destroy the product under FDA supervision at [redacted] in [redacted] on October 11, 2001. During the destruction our investigation revealed significant discrepancies:

  • Five additional variations of the retail unit label. These variations included an altered ingredient, net weight and firm statement and label format modifications.
  • Original master carton label, identified by the sampling FDA. investigator, consisted of red lettering and a white box. During ?he destruction the first top three rows of the pallet were identified as the mentioned original master carton label and the remainder was not. The remaining master carton labels consisted of an adhesive label with black lettering placed on a white box originally labeled as "***FROZEN STEAMED MACKEREL FISH***".

Your actions of commingling an entry to be violative for the presence of Salmonella, a poisonous and deleterious substance with other product has caused this entry to be adulterated within the meaning of 21 U.S.C. 342 (b)(2).

The following are previous entries whereby product was presented for destruction under FDA supervision and found adulterated within the meaning of 21 U.S.C. 342(b)(2), and annotated on the Customs form 3499 (Application and Approval to Manipulate, Examine, Sample or Transfer Goods):

Entry Number

Product

Invoiced Quantity

880-0025673-0/3/1

Black Pepper

[redacted] cartons

880-0026223-3/7/1

Dried Bamboo Shoot

[redacted] cartons

In addition both entries listed were FDA sampled, detained and Refused Admission since the products were found to be adulterated in whole or in part of a filthy, putrid, or decomposed substance or otherwise unfit for foot within the meaning of the Food, Drug & Cosmetic Act 402(a)(3).

Failure to promptly correct this violation and prevent future violations may result in requiring tit future shipments be held in secured storage. Secured storage will be under the supervision and direction of U. S. Customs, such as in a bonded warehouse. You will be responsible for all costs incurred at secured storage as well as to ensure that imported product meets all requirements of the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder.

Within 15 working days of receipt of-his letter, please notify this office in writing of the specific steps you have taken to correct the violation including an explanation of each step being taken to prevent the recurrence of the violation.

A copy of this letter, except for any confidential, personal, or commercial information will be placed on public display no earlier than fifteen (15) days after the date of this letter. Your response will be on public display with any confidential, personal, or commercial information purged.

Please send your reply to Food and Drug Administration, Attention: Ruth Dixon, Compliance Officer, 222 West 6th Street, Suite 700, San Pedro, CA 90731. If you have questions regarding any issue in this letter, please contact Ms. Dixon at (310) 831-6123, ext. 155.

Sincerely,
Alonza Cruse
District Director