LABORATORIO RAAM DE SAHUAYO S.A. DE C.V.
⚠️ High Risk
FEI: 3011627312 • Sahuayo, Michoacan • MEXICO
FEI Number
3011627312
Location
Sahuayo, Michoacan
Country
MEXICOAddress
Boulevard Lazaro Cardenas Sur No 794, Col. Noria De Montes, Sahuayo, Michoacan, 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 |
|---|---|---|---|
| 9/20/2024 | 64BDY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2024 | 60LCE69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2022 | 61XCA09CINNARIZINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIO RAAM DE SAHUAYO S.A. DE C.V.'s FDA import refusal history?
LABORATORIO RAAM DE SAHUAYO S.A. DE C.V. (FEI: 3011627312) has 3 FDA import refusal record(s) in our database, spanning from 9/23/2022 to 9/20/2024.
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. LABORATORIO RAAM DE SAHUAYO S.A. DE C.V.'s FEI number is 3011627312.
What types of violations has LABORATORIO RAAM DE SAHUAYO S.A. DE C.V. received?
LABORATORIO RAAM DE SAHUAYO S.A. DE C.V. 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 LABORATORIO RAAM DE SAHUAYO S.A. DE C.V. come from?
All FDA import refusal data for LABORATORIO RAAM DE SAHUAYO 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.