Medirama Sa De Cv
⚠️ Moderate Risk
FEI: 3000976541 • Tijuana, BC • MEXICO
FEI Number
3000976541
Location
Tijuana, BC
Country
MEXICOAddress
Ave Revolucion 943, , Tijuana, BC, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/16/2003 | 65GDS04MEQUINOL, 2%/TRETINOIN, 0.01% (PIGMENTATION AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2003 | 60LDY80ERGOTAMINE TARTRATE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/21/2002 | 65JDK21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Medirama Sa De Cv's FDA import refusal history?
Medirama Sa De Cv (FEI: 3000976541) has 3 FDA import refusal record(s) in our database, spanning from 6/21/2002 to 9/16/2003.
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. Medirama Sa De Cv's FEI number is 3000976541.
What types of violations has Medirama Sa De Cv received?
Medirama Sa De Cv 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 Medirama Sa De Cv come from?
All FDA import refusal data for Medirama 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.