ImportRefusal LogoImportRefusal

NUTRIBIOTECH CO LTD

⚠️ Moderate Risk

FEI: 3012539658 • Seoul • SOUTH KOREA

FEI

FEI Number

3012539658

📍

Location

Seoul

🇰🇷
🏢

Address

3f Summit Bldg 10 Nonhy, Gu, Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

18
Total Refusals
6
Unique Violations
10/11/2016
Latest Refusal
10/11/2016
Earliest Refusal

Score Breakdown

Violation Severity
49.6×40%
Refusal Volume
47.4×30%
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

23818×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

32416×

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)).

47311×

LABELING

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

48211×

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.

2189×

LIST INGRE

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)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3216×

LACKS N/C

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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
324NO ENGLISH
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
324NO ENGLISH
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
324NO ENGLISH
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
324NO ENGLISH
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
324NO ENGLISH
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
324NO ENGLISH
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
238UNSAFE ADD
324NO ENGLISH
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
321LACKS N/C
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
321LACKS N/C
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
321LACKS N/C
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
321LACKS N/C
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
321LACKS N/C
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
10/11/2016
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
218LIST INGRE
238UNSAFE ADD
321LACKS N/C
324NO ENGLISH
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is NUTRIBIOTECH CO LTD's FDA import refusal history?

NUTRIBIOTECH CO LTD (FEI: 3012539658) has 18 FDA import refusal record(s) in our database, spanning from 10/11/2016 to 10/11/2016.

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. NUTRIBIOTECH CO LTD's FEI number is 3012539658.

What types of violations has NUTRIBIOTECH CO LTD received?

NUTRIBIOTECH CO LTD has been cited for 6 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 NUTRIBIOTECH CO LTD come from?

All FDA import refusal data for NUTRIBIOTECH 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.