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Siegfried Rhein Sa De Cv

⚠️ Moderate Risk

FEI: 3004631630 • Mexico D.F • MEXICO

FEI

FEI Number

3004631630

📍

Location

Mexico D.F

🇲🇽

Country

MEXICO
🏢

Address

Mante Elbriz Piso No 12440, , Mexico D.F, , Mexico

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/22/2020
Latest Refusal
8/24/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
3.3×10%
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

753×

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
8/22/2020
62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/8/2017
62GCY94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/24/2011
56JCE20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Siegfried Rhein Sa De Cv's FDA import refusal history?

Siegfried Rhein Sa De Cv (FEI: 3004631630) has 3 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 8/22/2020.

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. Siegfried Rhein Sa De Cv's FEI number is 3004631630.

What types of violations has Siegfried Rhein Sa De Cv received?

Siegfried Rhein Sa De Cv has been cited for 1 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 Siegfried Rhein Sa De Cv come from?

All FDA import refusal data for Siegfried Rhein Sa De Cv 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.