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HAI DANG INT'L TRADING SERVICES CO LTD

⚠️ Moderate Risk

FEI: 2000037493 • Ho Chi Minh, VN-NOTA • VIETNAM

FEI

FEI Number

2000037493

📍

Location

Ho Chi Minh, VN-NOTA

🇻🇳

Country

VIETNAM
🏢

Address

220/18 Ho Van Hue St, Phu Nhuan District, Ho Chi Minh, VN-NOTA, Vietnam

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
4/26/2007
Latest Refusal
4/26/2007
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

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).

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
4/26/2007
60QBK67LIDOCAINE (ANESTHETIC)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is HAI DANG INT'L TRADING SERVICES CO LTD's FDA import refusal history?

HAI DANG INT'L TRADING SERVICES CO LTD (FEI: 2000037493) has 1 FDA import refusal record(s) in our database, spanning from 4/26/2007 to 4/26/2007.

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. HAI DANG INT'L TRADING SERVICES CO LTD's FEI number is 2000037493.

What types of violations has HAI DANG INT'L TRADING SERVICES CO LTD received?

HAI DANG INT'L TRADING SERVICES 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 HAI DANG INT'L TRADING SERVICES CO LTD come from?

All FDA import refusal data for HAI DANG INT'L TRADING SERVICES 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.