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Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant)

✅ Low Risk

FEI: 3003409739 • Yasu, Shiga • JAPAN

FEI

FEI Number

3003409739

📍

Location

Yasu, Shiga

🇯🇵

Country

JAPAN
🏢

Address

495-1, Mitcami, Yasu, Shiga, Japan

Low Risk

FDA Import Risk Assessment

22.6
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
4
Unique Violations
10/16/2006
Latest Refusal
10/16/2006
Earliest Refusal

Score Breakdown

Violation Severity
38.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4822×

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.

3201×

LACKS FIRM

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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3281×

USUAL NAME

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(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

Refusal History

DateProductViolationsDivision
10/16/2006
41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
328USUAL NAME
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)
10/16/2006
41BFY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
320LACKS FIRM
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant)'s FDA import refusal history?

Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant) (FEI: 3003409739) has 2 FDA import refusal record(s) in our database, spanning from 10/16/2006 to 10/16/2006.

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. Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant)'s FEI number is 3003409739.

What types of violations has Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant) received?

Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant) 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 Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant) come from?

All FDA import refusal data for Sun Chlorella Corp. (Qualitech Pharma Co., Ltd Shiga Plant) 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.