HAPROSIMEX

⚠️ Moderate Risk

FEI: 3012857472 • Ho Chi Minh • VIETNAM

FEI

FEI Number

3012857472

📍

Location

Ho Chi Minh

🇻🇳

Country

VIETNAM

🏢

Address

79, 77, Pho Duc Chinh St., Ho Chi Minh, , Vietnam

Moderate Risk

FDA Import Risk Assessment

38.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/27/2015

Latest Refusal

2/3/2015

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

41.3×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

11812×

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).

34112×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
2/27/2015	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/27/2015	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/23/2015	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/23/2015	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/23/2015	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/3/2015	76EFTCLEANSER, DENTURE, OTC	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/3/2015	76EFTCLEANSER, DENTURE, OTC	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/3/2015	76EFTCLEANSER, DENTURE, OTC	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/3/2015	76EFTCLEANSER, DENTURE, OTC	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/3/2015	76EFTCLEANSER, DENTURE, OTC	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/3/2015	76EFTCLEANSER, DENTURE, OTC	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/3/2015	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)

Frequently Asked Questions

What is HAPROSIMEX's FDA import refusal history?

HAPROSIMEX (FEI: 3012857472) has 12 FDA import refusal record(s) in our database, spanning from 2/3/2015 to 2/27/2015.

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. HAPROSIMEX's FEI number is 3012857472.

What types of violations has HAPROSIMEX received?

HAPROSIMEX 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 HAPROSIMEX come from?

All FDA import refusal data for HAPROSIMEX 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.