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MEIJI CO. LTD.

⚠️ Moderate Risk

FEI: 3013006796 • Koto, Tokyo • JAPAN

FEI

FEI Number

3013006796

📍

Location

Koto, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

(Kabu) Meiji, 1 Chome 2-10; Shinsuna, Koto, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

28.9
LowModerateHighCritical

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

Statistics

11
Total Refusals
4
Unique Violations
3/8/2017
Latest Refusal
3/13/2014
Earliest Refusal

Score Breakdown

Violation Severity
33.1×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
36.8×10%
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

32410×

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)).

4824×

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.

3211×

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.

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Refusal History

DateProductViolationsDivision
3/8/2017
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
324NO ENGLISH
3864NCONTACT
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
3/8/2017
40MGY01PROTEIN COMPONENT, INFANT FORMULA RAW MATERIAL COMPONENT
324NO ENGLISH
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
3/8/2017
05YYY01GRANOLA BARS
324NO ENGLISH
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
8/17/2016
54YCZ08COENZYME Q10 (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
324NO ENGLISH
482NUTRIT LBL
Division of Southeast Imports (DSEI)
9/29/2015
46YG99FOOD ADDITIVES FOR HUMAN USE, N.E.C.
324NO ENGLISH
New Orleans District Office (NOL-DO)
9/29/2015
46YG99FOOD ADDITIVES FOR HUMAN USE, N.E.C.
321LACKS N/C
New Orleans District Office (NOL-DO)
8/28/2015
33LHT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
324NO ENGLISH
Cincinnati District Office (CIN-DO)
11/19/2014
54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)
11/19/2014
54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)
11/19/2014
54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)
3/13/2014
54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is MEIJI CO. LTD.'s FDA import refusal history?

MEIJI CO. LTD. (FEI: 3013006796) has 11 FDA import refusal record(s) in our database, spanning from 3/13/2014 to 3/8/2017.

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. MEIJI CO. LTD.'s FEI number is 3013006796.

What types of violations has MEIJI CO. LTD. received?

MEIJI CO. LTD. has been cited for 4 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 MEIJI CO. LTD. come from?

All FDA import refusal data for MEIJI 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.