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SC PlantExtrakt

⚠️ Moderate Risk

FEI: 3010698715 • Radaia, Cluj • ROMANIA

FEI

FEI Number

3010698715

📍

Location

Radaia, Cluj

🇷🇴

Country

ROMANIA
🏢

Address

Zalaului f.n., , Radaia, Cluj, Romania

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/21/2017
Latest Refusal
2/21/2017
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/21/2017
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
3280FRNMFGREG
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is SC PlantExtrakt's FDA import refusal history?

SC PlantExtrakt (FEI: 3010698715) has 1 FDA import refusal record(s) in our database, spanning from 2/21/2017 to 2/21/2017.

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. SC PlantExtrakt's FEI number is 3010698715.

What types of violations has SC PlantExtrakt received?

SC PlantExtrakt 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 SC PlantExtrakt come from?

All FDA import refusal data for SC PlantExtrakt 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.