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HARBIN YEEKONG HERB INC.

⚠️ Moderate Risk

FEI: 3007031009 • Haerbin, Heilongjiang • CHINA

FEI

FEI Number

3007031009

📍

Location

Haerbin, Heilongjiang

🇨🇳

Country

CHINA
🏢

Address

Concentration, No 39 Huanghai Lu; District, Developmemt Area, Haerbin, Heilongjiang, China

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
10/18/2012
Latest Refusal
9/16/2009
Earliest Refusal

Score Breakdown

Violation Severity
72.5×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.5×10%
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

752×

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.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
10/18/2012
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
9/16/2009
80FRLFIBER, MEDICAL, ABSORBENT
223FALSE
483DRUG NAME
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is HARBIN YEEKONG HERB INC.'s FDA import refusal history?

HARBIN YEEKONG HERB INC. (FEI: 3007031009) has 2 FDA import refusal record(s) in our database, spanning from 9/16/2009 to 10/18/2012.

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. HARBIN YEEKONG HERB INC.'s FEI number is 3007031009.

What types of violations has HARBIN YEEKONG HERB INC. received?

HARBIN YEEKONG HERB INC. has been cited for 3 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 HARBIN YEEKONG HERB INC. come from?

All FDA import refusal data for HARBIN YEEKONG HERB 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.