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Weimer Pharma Gmbh

⚠️ Moderate Risk

FEI: 3000256561 • Rastatt, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3000256561

📍

Location

Rastatt, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Im Steingerust 30, , Rastatt, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/18/2012
Latest Refusal
10/27/2011
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
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

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).

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.

Refusal History

DateProductViolationsDivision
4/18/2012
61LBY99ANTI-COAGULANT, N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/27/2011
54YCB07BIOFLAVANOIDS (VIT/MIN?PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
260FALSE
75UNAPPROVED
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Weimer Pharma Gmbh's FDA import refusal history?

Weimer Pharma Gmbh (FEI: 3000256561) has 2 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 4/18/2012.

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. Weimer Pharma Gmbh's FEI number is 3000256561.

What types of violations has Weimer Pharma Gmbh received?

Weimer Pharma Gmbh 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 Weimer Pharma Gmbh come from?

All FDA import refusal data for Weimer Pharma Gmbh 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.