ESPECIALIDADES MEDICAM DMC
⚠️ High Risk
FEI: 3013132509 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3013132509
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle C No 21, Col. Educacion, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/19/2025 | 62GCY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 1/25/2017 | 64LDA03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ESPECIALIDADES MEDICAM DMC's FDA import refusal history?
ESPECIALIDADES MEDICAM DMC (FEI: 3013132509) has 3 FDA import refusal record(s) in our database, spanning from 1/25/2017 to 11/19/2025.
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. ESPECIALIDADES MEDICAM DMC's FEI number is 3013132509.
What types of violations has ESPECIALIDADES MEDICAM DMC received?
ESPECIALIDADES MEDICAM DMC 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 ESPECIALIDADES MEDICAM DMC come from?
All FDA import refusal data for ESPECIALIDADES MEDICAM DMC 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.