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Remedia Homoeopath

⚠️ High Risk

FEI: 3007921295 • Eisenstadt, Burgenland • AUSTRIA

FEI

FEI Number

3007921295

📍

Location

Eisenstadt, Burgenland

🇦🇹

Country

AUSTRIA
🏢

Address

Hauptstrasse 4, , Eisenstadt, Burgenland, Austria

High Risk

FDA Import Risk Assessment

50.8
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
2
Unique Violations
2/23/2011
Latest Refusal
1/31/2011
Earliest Refusal

Score Breakdown

Violation Severity
84.3×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

755×

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).

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
2/23/2011
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/23/2011
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/23/2011
66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/23/2011
66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/23/2011
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/23/2011
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
New Orleans District Office (NOL-DO)
1/31/2011
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Remedia Homoeopath's FDA import refusal history?

Remedia Homoeopath (FEI: 3007921295) has 7 FDA import refusal record(s) in our database, spanning from 1/31/2011 to 2/23/2011.

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. Remedia Homoeopath's FEI number is 3007921295.

What types of violations has Remedia Homoeopath received?

Remedia Homoeopath 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 Remedia Homoeopath come from?

All FDA import refusal data for Remedia Homoeopath 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.