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PH EWMAR-NESS

⚠️ Moderate Risk

FEI: 3017102909 • Sosnowiec, Slaskie • POLAND

FEI

FEI Number

3017102909

📍

Location

Sosnowiec, Slaskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Gen. Mariusza Zaruskiego 3, , Sosnowiec, Slaskie, Poland

Moderate Risk

FDA Import Risk Assessment

26.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/26/2022
Latest Refusal
10/26/2022
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
21.8×20%
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

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Refusal History

DateProductViolationsDivision
10/26/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
3864NCONTACT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PH EWMAR-NESS's FDA import refusal history?

PH EWMAR-NESS (FEI: 3017102909) has 1 FDA import refusal record(s) in our database, spanning from 10/26/2022 to 10/26/2022.

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. PH EWMAR-NESS's FEI number is 3017102909.

What types of violations has PH EWMAR-NESS received?

PH EWMAR-NESS 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 PH EWMAR-NESS come from?

All FDA import refusal data for PH EWMAR-NESS 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.