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Wuhan Longke Biotechnology Co., Ltd.

⚠️ Moderate Risk

FEI: 3015436847 • Wuhan, Hubei • CHINA

FEI

FEI Number

3015436847

📍

Location

Wuhan, Hubei

🇨🇳

Country

CHINA
🏢

Address

No. 199 Shendun Road, , Wuhan, Hubei, China

Moderate Risk

FDA Import Risk Assessment

32.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/2/2022
Latest Refusal
9/2/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
18.8×20%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

DateProductViolationsDivision
9/2/2022
60QCT46PROCAINE HCL (ANESTHETIC)
2280DIRSEXMPT
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Wuhan Longke Biotechnology Co., Ltd.'s FDA import refusal history?

Wuhan Longke Biotechnology Co., Ltd. (FEI: 3015436847) has 1 FDA import refusal record(s) in our database, spanning from 9/2/2022 to 9/2/2022.

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. Wuhan Longke Biotechnology Co., Ltd.'s FEI number is 3015436847.

What types of violations has Wuhan Longke Biotechnology Co., Ltd. received?

Wuhan Longke Biotechnology Co., Ltd. has been cited for 1 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 Wuhan Longke Biotechnology Co., Ltd. come from?

All FDA import refusal data for Wuhan Longke Biotechnology 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.