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Wuhan Fulai Pharmaceutical Technology Co., Ltd

⚠️ Moderate Risk

FEI: 3010165393 • Wuhan, Hubei • CHINA

FEI

FEI Number

3010165393

📍

Location

Wuhan, Hubei

🇨🇳

Country

CHINA
🏢

Address

Wuhuan Industrial Park, Xinji, , Wuhan, Hubei, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/14/2016
Latest Refusal
9/14/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

751×

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
9/14/2016
60LBY99ANALGESIC, N.E.C.
3280FRNMFGREG
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wuhan Fulai Pharmaceutical Technology Co., Ltd's FDA import refusal history?

Wuhan Fulai Pharmaceutical Technology Co., Ltd (FEI: 3010165393) has 1 FDA import refusal record(s) in our database, spanning from 9/14/2016 to 9/14/2016.

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 Fulai Pharmaceutical Technology Co., Ltd's FEI number is 3010165393.

What types of violations has Wuhan Fulai Pharmaceutical Technology Co., Ltd received?

Wuhan Fulai Pharmaceutical Technology Co., Ltd 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 Wuhan Fulai Pharmaceutical Technology Co., Ltd come from?

All FDA import refusal data for Wuhan Fulai Pharmaceutical Technology 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.