LABORATORIOS RAAM DE SAHUAYO
⚠️ High Risk
FEI: 3012387732 • Guadalajara • MEXICO
FEI Number
3012387732
Location
Guadalajara
Country
MEXICOAddress
Blvd Lazaro Cardenas Su, , Guadalajara, , 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 |
|---|---|---|---|
| 10/20/2025 | 62KCA02DIFENOXIN (ANTI-PERISTALTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2021 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2019 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 61XDY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 66TLB01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2016 | 62GDA94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is LABORATORIOS RAAM DE SAHUAYO's FDA import refusal history?
LABORATORIOS RAAM DE SAHUAYO (FEI: 3012387732) has 7 FDA import refusal record(s) in our database, spanning from 11/9/2016 to 10/20/2025.
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 RAAM DE SAHUAYO's FEI number is 3012387732.
What types of violations has LABORATORIOS RAAM DE SAHUAYO received?
LABORATORIOS RAAM DE SAHUAYO 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 RAAM DE SAHUAYO come from?
All FDA import refusal data for LABORATORIOS RAAM DE SAHUAYO 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.