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Ebi-Electronic Ag

⚠️ Moderate Risk

FEI: 3008870415 • Kirchlindach, Bern • SWITZERLAND

FEI

FEI Number

3008870415

📍

Location

Kirchlindach, Bern

🇨🇭
🏢

Address

Lindachstrasse 8c, , Kirchlindach, Bern, Switzerland

Moderate Risk

FDA Import Risk Assessment

40.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
6/24/2011
Latest Refusal
6/24/2011
Earliest Refusal

Score Breakdown

Violation Severity
62.5×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

754×

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).

3242×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
6/24/2011
54ACY99VITAMIN, N.E.C.
324NO ENGLISH
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/24/2011
54ACY99VITAMIN, N.E.C.
324NO ENGLISH
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/24/2011
54AFL13VITAMIN C (ASCORBIC ACID)
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/24/2011
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/24/2011
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/24/2011
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ebi-Electronic Ag's FDA import refusal history?

Ebi-Electronic Ag (FEI: 3008870415) has 6 FDA import refusal record(s) in our database, spanning from 6/24/2011 to 6/24/2011.

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. Ebi-Electronic Ag's FEI number is 3008870415.

What types of violations has Ebi-Electronic Ag received?

Ebi-Electronic Ag has been cited for 3 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 Ebi-Electronic Ag come from?

All FDA import refusal data for Ebi-Electronic Ag 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.