Asofarma De Mexico, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3004706868 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3004706868
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Mexico-Xochimilco No. 43, Pueblo San Lorenzo Huipulco, Tlalpan, Ciudad De Mexico, Ciudad de Mexico, 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).
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 |
|---|---|---|---|
| 6/8/2016 | 56YDA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/18/2015 | 61UAY05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/3/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/5/2007 | 61UCA05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/9/2006 | 62QDA99ANTI-RHEUMATIC N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Asofarma De Mexico, S.A. De C.V.'s FDA import refusal history?
Asofarma De Mexico, S.A. De C.V. (FEI: 3004706868) has 5 FDA import refusal record(s) in our database, spanning from 8/9/2006 to 6/8/2016.
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 C.V.'s FEI number is 3004706868.
What types of violations has Asofarma De Mexico, S.A. De C.V. received?
Asofarma De Mexico, S.A. De C.V. 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 Asofarma De Mexico, S.A. De C.V. come from?
All FDA import refusal data for Asofarma De Mexico, 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.