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BEST LINKAGE

⚠️ Moderate Risk

FEI: 3012046895 • Kako-Gun, Hyogo • JAPAN

FEI

FEI Number

3012046895

📍

Location

Kako-Gun, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

876-1, Nakaishiki; Inami-Cho, Kako-Gun, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

48.7
LowModerateHighCritical

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

Statistics

10
Total Refusals
4
Unique Violations
5/3/2019
Latest Refusal
2/1/2017
Earliest Refusal

Score Breakdown

Violation Severity
81.8×40%
Refusal Volume
38.6×30%
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

628×

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).

111×

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).

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.

831×

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
5/3/2019
29AGE99NONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
11/14/2018
16AGH01ANCHOVY
308MFR INSAN
Division of West Coast Imports (DWCI)
2/1/2017
23RGE02SESAME SEED (EDIBLE SEED PASTE)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
2/1/2017
23RGE02SESAME SEED (EDIBLE SEED PASTE)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
2/1/2017
02DHE05RICE MEAL PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
2/1/2017
02DHE05RICE MEAL PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
2/1/2017
02DHE05RICE MEAL PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
2/1/2017
02DHE05RICE MEAL PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
2/1/2017
02DHE05RICE MEAL PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
2/1/2017
33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is BEST LINKAGE's FDA import refusal history?

BEST LINKAGE (FEI: 3012046895) has 10 FDA import refusal record(s) in our database, spanning from 2/1/2017 to 5/3/2019.

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. BEST LINKAGE's FEI number is 3012046895.

What types of violations has BEST LINKAGE received?

BEST LINKAGE 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 BEST LINKAGE come from?

All FDA import refusal data for BEST LINKAGE 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.