LOEFFLER SA DE CV
⚠️ High Risk
FEI: 3013335298 • MEXICO DF • MEXICO
FEI Number
3013335298
Location
MEXICO DF
Country
MEXICOAddress
PROLONGACION ING. MILIT, , MEXICO DF, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2023 | 62GCY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2022 | 60QAY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2019 | 60SDR99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LOEFFLER SA DE CV's FDA import refusal history?
LOEFFLER SA DE CV (FEI: 3013335298) has 5 FDA import refusal record(s) in our database, spanning from 5/12/2017 to 3/9/2023.
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. LOEFFLER SA DE CV's FEI number is 3013335298.
What types of violations has LOEFFLER SA DE CV received?
LOEFFLER SA 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 LOEFFLER SA DE CV come from?
All FDA import refusal data for LOEFFLER 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.