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Donggang Hongda Pharmaceutical Co., Ltd.

✅ Low Risk

FEI: 3005851709 • Donggang, Liaoning • CHINA

FEI

FEI Number

3005851709

📍

Location

Donggang, Liaoning

🇨🇳

Country

CHINA
🏢

Address

No. 8 Gongye Road, Qianyang Town, Donggang, Liaoning, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
12/8/2010
Latest Refusal
12/8/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/8/2010
61TCS17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT)
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Donggang Hongda Pharmaceutical Co., Ltd.'s FDA import refusal history?

Donggang Hongda Pharmaceutical Co., Ltd. (FEI: 3005851709) has 1 FDA import refusal record(s) in our database, spanning from 12/8/2010 to 12/8/2010.

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. Donggang Hongda Pharmaceutical Co., Ltd.'s FEI number is 3005851709.

What types of violations has Donggang Hongda Pharmaceutical Co., Ltd. received?

Donggang Hongda Pharmaceutical 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 Donggang Hongda Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Donggang Hongda Pharmaceutical 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.