Procter & Gamble Hyginett Kft.

⚠️ Moderate Risk

FEI: 3013504555 • Gyongyos, Heves • HUNGARY

FEI

FEI Number

3013504555

📍

Location

Gyongyos, Heves

🇭🇺

Country

HUNGARY

🏢

Address

Jedlik Anyos Utca 2-4, , Gyongyos, Heves, Hungary

Moderate Risk

FDA Import Risk Assessment

43.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/24/2023

Latest Refusal

9/24/2020

Earliest Refusal

Score Breakdown

Violation Severity

43.9×40%

Refusal Volume

37.0×30%

Recency

57.4×20%

Frequency

28.4×10%

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

1189×

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).

3414×

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
11/24/2023	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED	Division of Southeast Imports (DSEI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED 341REGISTERED	Division of Southwest Imports (DSWI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED 341REGISTERED	Division of Southwest Imports (DSWI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED 341REGISTERED	Division of Southwest Imports (DSWI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED 341REGISTERED	Division of Southwest Imports (DSWI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED	Division of Southwest Imports (DSWI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED	Division of Southwest Imports (DSWI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED	Division of Southwest Imports (DSWI)
9/24/2020	85HHDPAD, MENSTRUAL, UNSCENTED	118NOT LISTED	Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Procter & Gamble Hyginett Kft.'s FDA import refusal history?

Procter & Gamble Hyginett Kft. (FEI: 3013504555) has 9 FDA import refusal record(s) in our database, spanning from 9/24/2020 to 11/24/2023.

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. Procter & Gamble Hyginett Kft.'s FEI number is 3013504555.

What types of violations has Procter & Gamble Hyginett Kft. received?

Procter & Gamble Hyginett Kft. 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 Procter & Gamble Hyginett Kft. come from?

All FDA import refusal data for Procter & Gamble Hyginett Kft. 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.