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Hyginett Hungarian American Co. for the Prod. of Hygienic Pr

✅ Low Risk

FEI: 3004443383 • Csomor, Pest • HUNGARY

FEI

FEI Number

3004443383

📍

Location

Csomor, Pest

🇭🇺

Country

HUNGARY
🏢

Address

Hatar ut 3, , Csomor, Pest, Hungary

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/8/2011
Latest Refusal
4/8/2011
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

3411×

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

DateProductViolationsDivision
4/8/2011
85HHDPAD, MENSTRUAL, UNSCENTED
3260NO ENGLISH
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Hyginett Hungarian American Co. for the Prod. of Hygienic Pr's FDA import refusal history?

Hyginett Hungarian American Co. for the Prod. of Hygienic Pr (FEI: 3004443383) has 1 FDA import refusal record(s) in our database, spanning from 4/8/2011 to 4/8/2011.

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. Hyginett Hungarian American Co. for the Prod. of Hygienic Pr's FEI number is 3004443383.

What types of violations has Hyginett Hungarian American Co. for the Prod. of Hygienic Pr received?

Hyginett Hungarian American Co. for the Prod. of Hygienic Pr 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 Hyginett Hungarian American Co. for the Prod. of Hygienic Pr come from?

All FDA import refusal data for Hyginett Hungarian American Co. for the Prod. of Hygienic Pr 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.