ASOFARMA DE MEXICO, S.A. DE CV
⚠️ Moderate Risk
FEI: 3013091083 • Distrito Federa • MEXICO
FEI Number
3013091083
Location
Distrito Federa
Country
MEXICOAddress
Calzada Mexico Xochimil, , Distrito Federa, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2020 | 61XDB99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 62YDY07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 65JCY31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2017 | 60TCA99ANTAGONIST, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ASOFARMA DE MEXICO, S.A. DE CV's FDA import refusal history?
ASOFARMA DE MEXICO, S.A. DE CV (FEI: 3013091083) has 4 FDA import refusal record(s) in our database, spanning from 2/24/2017 to 6/17/2020.
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. ASOFARMA DE MEXICO, S.A. DE CV's FEI number is 3013091083.
What types of violations has ASOFARMA DE MEXICO, S.A. DE CV received?
ASOFARMA DE MEXICO, S.A. 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 ASOFARMA DE MEXICO, S.A. DE CV come from?
All FDA import refusal data for ASOFARMA DE MEXICO, S.A. 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.