Siegfried Rhein S.A. DE C.V.
⚠️ High Risk
FEI: 3002881106 • Queretaro, QRO • MEXICO
FEI Number
3002881106
Location
Queretaro, QRO
Country
MEXICOAddress
Calle 2 no. 30 Fracc. Ind. Benito Juarez, , Queretaro, QRO, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/6/2023 | 62ODY19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 61PCE31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2020 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2020 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2019 | 62GDA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2017 | 56CCK71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/9/2016 | 62GCA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Siegfried Rhein S.A. DE C.V.'s FDA import refusal history?
Siegfried Rhein S.A. DE C.V. (FEI: 3002881106) has 7 FDA import refusal record(s) in our database, spanning from 12/9/2016 to 10/6/2023.
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 S.A. DE C.V.'s FEI number is 3002881106.
What types of violations has Siegfried Rhein S.A. DE C.V. received?
Siegfried Rhein S.A. DE C.V. 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 S.A. DE C.V. come from?
All FDA import refusal data for Siegfried Rhein S.A. DE C.V. 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.