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MSC Co.,Ltd.

⚠️ Moderate Risk

FEI: 3004250909 • Yangsan • SOUTH KOREA

FEI

FEI Number

3004250909

📍

Location

Yangsan

🇰🇷
🏢

Address

439-13 Sojuri, Ungsangup, , Yangsan, , South Korea

Moderate Risk

FDA Import Risk Assessment

46.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
2/16/2007
Latest Refusal
10/12/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.8×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
44.5×10%
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

626×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

836×

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.

3081×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

Refusal History

DateProductViolationsDivision
2/16/2007
29AHT99NONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
8/28/2006
16AEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
8/28/2006
16AEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
8/28/2006
16AEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
10/12/2005
29AET99NONCARBONATED SOFT DRINK, N.E.C.
308MFR INSAN
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
10/12/2005
29AET99NONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

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

MSC Co.,Ltd. (FEI: 3004250909) has 6 FDA import refusal record(s) in our database, spanning from 10/12/2005 to 2/16/2007.

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. MSC Co.,Ltd.'s FEI number is 3004250909.

What types of violations has MSC Co.,Ltd. received?

MSC Co.,Ltd. has been cited for 3 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 MSC Co.,Ltd. come from?

All FDA import refusal data for MSC 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.