SIEGFRIED RHEIN SA DE CV
⚠️ Moderate Risk
FEI: 3012613962 • Mexico City • MEXICO
FEI Number
3012613962
Location
Mexico City
Country
MEXICOAddress
Antonio Dovali NO 70 TO, , Mexico City, , Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/7/2022 | 56JCH20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | Division of Southeast Imports (DSEI) | |
| 4/7/2022 | 60LCB80ERGOTAMINE TARTRATE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is SIEGFRIED RHEIN SA DE CV's FDA import refusal history?
SIEGFRIED RHEIN SA DE CV (FEI: 3012613962) has 4 FDA import refusal record(s) in our database, spanning from 8/15/2016 to 12/7/2022.
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 3012613962.
What types of violations has SIEGFRIED RHEIN SA DE CV received?
SIEGFRIED RHEIN SA DE CV 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 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.