LABORATORIOS SCHOEN SA DE CV
⚠️ High Risk
FEI: 3013671335 • Guadalajara, Jalisco • MEXICO
FEI Number
3013671335
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Calle Rio Tizapan No 1599, Unidad Habitacional Atlas, Guadalajara, Jalisco, 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 |
|---|---|---|---|
| 3/13/2024 | 60LBY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/20/2024 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2021 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2021 | 65QDA22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2019 | 64LDY19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2019 | 64BCB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIOS SCHOEN SA DE CV's FDA import refusal history?
LABORATORIOS SCHOEN SA DE CV (FEI: 3013671335) has 7 FDA import refusal record(s) in our database, spanning from 5/31/2019 to 3/13/2024.
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 SCHOEN SA DE CV's FEI number is 3013671335.
What types of violations has LABORATORIOS SCHOEN SA DE CV received?
LABORATORIOS SCHOEN 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 LABORATORIOS SCHOEN SA DE CV come from?
All FDA import refusal data for LABORATORIOS SCHOEN 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.