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Santa Trading Co., Ltd.

⚠️ Moderate Risk

FEI: 3004388794 • Nagoya, Aichi • JAPAN

FEI

FEI Number

3004388794

📍

Location

Nagoya, Aichi

🇯🇵

Country

JAPAN
🏢

Address

Helandori-2, Choma, Kita-Ku,462-816, 502-17 2; Heian; Kita, Nagoya, Aichi, Japan

Moderate Risk

FDA Import Risk Assessment

38.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

18
Total Refusals
11
Unique Violations
7/20/2012
Latest Refusal
8/30/2006
Earliest Refusal

Score Breakdown

Violation Severity
53.1×40%
Refusal Volume
47.4×30%
Recency
0.0×20%
Frequency
30.5×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1110×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2188×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

2748×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

2605×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

642×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

3212×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3241×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

3281×

USUAL NAME

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

Refusal History

DateProductViolationsDivision
7/20/2012
33EGT07JELLIED CANDIES, HARD (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Division of Northeast Imports (DNEI)
1/10/2012
33JGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
64YELLOW #5
Chicago District Office (CHI-DO)
1/10/2012
33JGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
64YELLOW #5
Chicago District Office (CHI-DO)
1/10/2012
33JGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Chicago District Office (CHI-DO)
1/10/2012
33JGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Chicago District Office (CHI-DO)
1/10/2012
33JGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Chicago District Office (CHI-DO)
1/10/2012
33JGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
Chicago District Office (CHI-DO)
1/10/2012
33JGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
Chicago District Office (CHI-DO)
7/8/2010
33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
New York District Office (NYK-DO)
11/10/2009
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
324NO ENGLISH
328USUAL NAME
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
10/19/2009
33JGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/6/2008
33JHB06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
5/6/2008
33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
8/30/2006
33BGE05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
218LIST INGRE
260FALSE
Los Angeles District Office (LOS-DO)
8/30/2006
33SGE99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
260FALSE
Los Angeles District Office (LOS-DO)
8/30/2006
33EGE99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
260FALSE
Los Angeles District Office (LOS-DO)
8/30/2006
33CGE06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
218LIST INGRE
260FALSE
Los Angeles District Office (LOS-DO)
8/30/2006
33MGE01GEL CUPS, FRUIT FLAVORED
218LIST INGRE
260FALSE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Santa Trading Co., Ltd.'s FDA import refusal history?

Santa Trading Co., Ltd. (FEI: 3004388794) has 18 FDA import refusal record(s) in our database, spanning from 8/30/2006 to 7/20/2012.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Santa Trading Co., Ltd.'s FEI number is 3004388794.

What types of violations has Santa Trading Co., Ltd. received?

Santa Trading Co., Ltd. has been cited for 11 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Santa Trading Co., Ltd. come from?

All FDA import refusal data for Santa Trading Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.