Nafar Laboratorios, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3006448769 • Rancho O Rancheria Agua Blanca Industrial, Jalisco • MEXICO
FEI Number
3006448769
Location
Rancho O Rancheria Agua Blanca Industrial, Jalisco
Country
MEXICOAddress
Calle Justo Sierra No. 933, Zapopan, Rancho O Rancheria Agua Blanca Industrial, Jalisco, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 7/31/2017 | 65PCB03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Nafar Laboratorios, S.A. de C.V.'s FDA import refusal history?
Nafar Laboratorios, S.A. de C.V. (FEI: 3006448769) has 1 FDA import refusal record(s) in our database, spanning from 7/31/2017 to 7/31/2017.
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. Nafar Laboratorios, S.A. de C.V.'s FEI number is 3006448769.
What types of violations has Nafar Laboratorios, S.A. de C.V. received?
Nafar Laboratorios, 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 Nafar Laboratorios, S.A. de C.V. come from?
All FDA import refusal data for Nafar Laboratorios, 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.