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Brilliant Pharma Co Ltd, ChengDu

⚠️ Moderate Risk

FEI: 3015807303 • Chengdu, Sichuan • CHINA

FEI

FEI Number

3015807303

📍

Location

Chengdu, Sichuan

🇨🇳

Country

CHINA
🏢

Address

No. 1166 Konggang 4th Road, , Chengdu, Sichuan, China

Moderate Risk

FDA Import Risk Assessment

37.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
5/29/2020
Latest Refusal
5/29/2020
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

23004×

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.

754×

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).

Refusal History

DateProductViolationsDivision
5/29/2020
54YBL02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
2300DIETARYLBL
75UNAPPROVED
Division of West Coast Imports (DWCI)
5/29/2020
54HBL07SOY LECITHIN (FATS AND LIPID SUBSTANCES)
2300DIETARYLBL
75UNAPPROVED
Division of West Coast Imports (DWCI)
5/29/2020
54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
75UNAPPROVED
Division of West Coast Imports (DWCI)
5/29/2020
54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Brilliant Pharma Co Ltd, ChengDu's FDA import refusal history?

Brilliant Pharma Co Ltd, ChengDu (FEI: 3015807303) has 4 FDA import refusal record(s) in our database, spanning from 5/29/2020 to 5/29/2020.

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. Brilliant Pharma Co Ltd, ChengDu's FEI number is 3015807303.

What types of violations has Brilliant Pharma Co Ltd, ChengDu received?

Brilliant Pharma Co Ltd, ChengDu has been cited for 2 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 Brilliant Pharma Co Ltd, ChengDu come from?

All FDA import refusal data for Brilliant Pharma Co Ltd, ChengDu 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.