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Aogrand International Group Inc.

⚠️ Moderate Risk

FEI: 3011183019 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3011183019

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Building 4, 205 Shuanggao Road; Town, Gaochun, Nanjing, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

47.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
9/9/2020
Latest Refusal
7/23/2020
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

755×

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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
9/9/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/2/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
75UNAPPROVED
Division of West Coast Imports (DWCI)
9/2/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
75UNAPPROVED
Division of West Coast Imports (DWCI)
9/2/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
75UNAPPROVED
Division of West Coast Imports (DWCI)
7/23/2020
62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL)
223FALSE
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Aogrand International Group Inc.'s FDA import refusal history?

Aogrand International Group Inc. (FEI: 3011183019) has 5 FDA import refusal record(s) in our database, spanning from 7/23/2020 to 9/9/2020.

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. Aogrand International Group Inc.'s FEI number is 3011183019.

What types of violations has Aogrand International Group Inc. received?

Aogrand International Group Inc. 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 Aogrand International Group Inc. come from?

All FDA import refusal data for Aogrand International Group Inc. 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.