ImportRefusal LogoImportRefusal

CCHANGZHOU JULANG BIOTECHNOLOGY

Low Risk

FEI: 3015922378 • Changzhou • CHINA

FEI

FEI Number

3015922378

📍

Location

Changzhou

🇨🇳

Country

CHINA
🏢

Address

18th Huanshang Rd, , Changzhou, , China

Low Risk

FDA Import Risk Assessment

21.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
6
Unique Violations
2/12/2020
Latest Refusal
2/12/2020
Earliest Refusal

Score Breakdown

Violation Severity
41.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2181×

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.

23001×

DIETARYLBL

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)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

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.

38621×

DIETARYING

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)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

38641×

NCONTACT

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(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
2/12/2020
54BYA99MINERAL N.E.C.
218LIST INGRE
2300DIETARYLBL
320LACKS FIRM
3862DIETARYING
3864NCONTACT
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CCHANGZHOU JULANG BIOTECHNOLOGY's FDA import refusal history?

CCHANGZHOU JULANG BIOTECHNOLOGY (FEI: 3015922378) has 1 FDA import refusal record(s) in our database, spanning from 2/12/2020 to 2/12/2020.

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. CCHANGZHOU JULANG BIOTECHNOLOGY's FEI number is 3015922378.

What types of violations has CCHANGZHOU JULANG BIOTECHNOLOGY received?

CCHANGZHOU JULANG BIOTECHNOLOGY 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 CCHANGZHOU JULANG BIOTECHNOLOGY come from?

All FDA import refusal data for CCHANGZHOU JULANG BIOTECHNOLOGY 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.