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SHINSEGAE DISTRIBUTION CO., LTD.

⚠️ Moderate Risk

FEI: 3007045159 • Buk, Gwangju Gwangyeogsi • SOUTH KOREA

FEI

FEI Number

3007045159

📍

Location

Buk, Gwangju Gwangyeogsi

🇰🇷
🏢

Address

491-5 Sinanng, , Buk, Gwangju Gwangyeogsi, South Korea

Moderate Risk

FDA Import Risk Assessment

34.7
LowModerateHighCritical

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

Statistics

13
Total Refusals
1
Unique Violations
8/14/2008
Latest Refusal
8/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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

32413×

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)).

Refusal History

DateProductViolationsDivision
8/14/2008
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
27YCT07SANDWICH SPREAD (SALAD DRESSING BASED)
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
16AGD99FISH, N.E.C.
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
16AGD01ANCHOVY
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
16AGH28POLLACK, POLLOCK
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
16MGH07CUTTLEFISH, OTHER AQUATIC SPECIES
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22')
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
16AGT55CORVINA
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
16AVD99FISH, N.E.C.
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
28SGT99SALT (TABLE SALT) N.E.C.
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
29AHN99NONCARBONATED SOFT DRINK, N.E.C.
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
31LFT99TEA, DECAFFEINATED, N.E.C.
324NO ENGLISH
Atlanta District Office (ATL-DO)
8/14/2008
03MGT99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.
324NO ENGLISH
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is SHINSEGAE DISTRIBUTION CO., LTD.'s FDA import refusal history?

SHINSEGAE DISTRIBUTION CO., LTD. (FEI: 3007045159) has 13 FDA import refusal record(s) in our database, spanning from 8/14/2008 to 8/14/2008.

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. SHINSEGAE DISTRIBUTION CO., LTD.'s FEI number is 3007045159.

What types of violations has SHINSEGAE DISTRIBUTION CO., LTD. received?

SHINSEGAE DISTRIBUTION CO., LTD. has been cited for 1 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 SHINSEGAE DISTRIBUTION CO., LTD. come from?

All FDA import refusal data for SHINSEGAE DISTRIBUTION 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.