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Korea Yakult Co., Ltd.

⚠️ Moderate Risk

FEI: 3002718616 • Choong Chung Puk-Do • SOUTH KOREA

FEI

FEI Number

3002718616

📍

Location

Choong Chung Puk-Do

🇰🇷
🏢

Address

3732 Kwanghyewon, , Choong Chung Puk-Do, , South Korea

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
9/4/2002
Latest Refusal
9/4/2002
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

834×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
9/4/2002
29AEE99NONCARBONATED SOFT DRINK, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)
9/4/2002
29AEE99NONCARBONATED SOFT DRINK, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)
9/4/2002
29AEE99NONCARBONATED SOFT DRINK, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)
9/4/2002
29AEE99NONCARBONATED SOFT DRINK, N.E.C.
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Korea Yakult Co., Ltd.'s FDA import refusal history?

Korea Yakult Co., Ltd. (FEI: 3002718616) has 4 FDA import refusal record(s) in our database, spanning from 9/4/2002 to 9/4/2002.

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. Korea Yakult Co., Ltd.'s FEI number is 3002718616.

What types of violations has Korea Yakult Co., Ltd. received?

Korea Yakult 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 Korea Yakult Co., Ltd. come from?

All FDA import refusal data for Korea Yakult 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.