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Gerhard Mann

⚠️ Moderate Risk

FEI: 1000453499 • Berlin • GERMANY

FEI

FEI Number

1000453499

📍

Location

Berlin

🇩🇪

Country

GERMANY
🏢

Address

Brunsbutter Demm 1651, PO 200456, Berlin, , Germany

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/30/2001
Latest Refusal
10/30/2001
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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.

752×

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
10/30/2001
41BCY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/30/2001
41BCY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Gerhard Mann's FDA import refusal history?

Gerhard Mann (FEI: 1000453499) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2001 to 10/30/2001.

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. Gerhard Mann's FEI number is 1000453499.

What types of violations has Gerhard Mann received?

Gerhard Mann 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 Gerhard Mann come from?

All FDA import refusal data for Gerhard Mann 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.