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Kunming Aoqun Bio-Tech Co,. Ltd

⚠️ High Risk

FEI: 3012262357 • Kunming, Yunnan • CHINA

FEI

FEI Number

3012262357

📍

Location

Kunming, Yunnan

🇨🇳

Country

CHINA
🏢

Address

Kunming National High & New Room 2nd, Floor;209 2188 No. Kegao Road, Kunming, Yunnan, China

High Risk

FDA Import Risk Assessment

63.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

12
Total Refusals
10
Unique Violations
3/6/2025
Latest Refusal
12/3/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.3×40%
Refusal Volume
41.3×30%
Recency
83.0×20%
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

1110×

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).

27410×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

2183×

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.

3202×

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.

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

3211×

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.

38631×

PLANT PART

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.

4821×

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.

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
3/6/2025
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
3/6/2025
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
3/6/2025
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
1/30/2025
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
1/30/2025
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
1/30/2025
54YCI99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
Division of West Coast Imports (DWCI)
12/11/2024
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
218LIST INGRE
260FALSE
3863PLANT PART
482NUTRIT LBL
75UNAPPROVED
Division of West Coast Imports (DWCI)
12/3/2024
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
178COL ADDED
75UNAPPROVED
Division of West Coast Imports (DWCI)
12/3/2024
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
75UNAPPROVED
Division of West Coast Imports (DWCI)
12/3/2024
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
12/3/2024
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
12/3/2024
54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Kunming Aoqun Bio-Tech Co,. Ltd's FDA import refusal history?

Kunming Aoqun Bio-Tech Co,. Ltd (FEI: 3012262357) has 12 FDA import refusal record(s) in our database, spanning from 12/3/2024 to 3/6/2025.

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. Kunming Aoqun Bio-Tech Co,. Ltd's FEI number is 3012262357.

What types of violations has Kunming Aoqun Bio-Tech Co,. Ltd received?

Kunming Aoqun Bio-Tech Co,. Ltd has been cited for 10 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 Kunming Aoqun Bio-Tech Co,. Ltd come from?

All FDA import refusal data for Kunming Aoqun Bio-Tech 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.