LABORATORIOS ALPHARMA S.A. DE C.
⚠️ High Risk
FEI: 3012993257 • Hidalgo • MEXICO
FEI Number
3012993257
Location
Hidalgo
Country
MEXICOAddress
Boulevard Pipila NO. 1, , Hidalgo, , 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 |
|---|---|---|---|
| 9/10/2024 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/12/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2020 | 61TBU12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2020 | 61NAU29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2018 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIOS ALPHARMA S.A. DE C.'s FDA import refusal history?
LABORATORIOS ALPHARMA S.A. DE C. (FEI: 3012993257) has 7 FDA import refusal record(s) in our database, spanning from 11/6/2018 to 9/10/2024.
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. LABORATORIOS ALPHARMA S.A. DE C.'s FEI number is 3012993257.
What types of violations has LABORATORIOS ALPHARMA S.A. DE C. received?
LABORATORIOS ALPHARMA S.A. DE C. 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 LABORATORIOS ALPHARMA S.A. DE C. come from?
All FDA import refusal data for LABORATORIOS ALPHARMA S.A. DE C. 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.