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Rang Dong S.P.CA Manufacturing Construction Trading Co Ltd

Low Risk

FEI: 3017113855 • Ho Chi Minh • VIETNAM

FEI

FEI Number

3017113855

📍

Location

Ho Chi Minh

🇻🇳

Country

VIETNAM
🏢

Address

440/6-8 Thong Nhat St, Ward 16, Go Vap District, Ho Chi Minh, , Vietnam

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
8/17/2020
Latest Refusal
8/17/2020
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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).

30001×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

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.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
8/17/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
3000N-RX INACT
3280FRNMFGREG
336INCONSPICU
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Rang Dong S.P.CA Manufacturing Construction Trading Co Ltd's FDA import refusal history?

Rang Dong S.P.CA Manufacturing Construction Trading Co Ltd (FEI: 3017113855) has 1 FDA import refusal record(s) in our database, spanning from 8/17/2020 to 8/17/2020.

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. Rang Dong S.P.CA Manufacturing Construction Trading Co Ltd's FEI number is 3017113855.

What types of violations has Rang Dong S.P.CA Manufacturing Construction Trading Co Ltd received?

Rang Dong S.P.CA Manufacturing Construction Trading Co Ltd has been cited for 4 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 Rang Dong S.P.CA Manufacturing Construction Trading Co Ltd come from?

All FDA import refusal data for Rang Dong S.P.CA Manufacturing Construction Trading 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.