Mas Natural Salud y Bienestar, S. de R.L. de C.V.
⚠️ Moderate Risk
FEI: 3010165400 • Irapuato, Guanajuato • MEXICO
FEI Number
3010165400
Location
Irapuato, Guanajuato
Country
MEXICOAddress
Calle Emilio Carranza No. 1055, Col. RODRIGUEZ, Irapuato, Guanajuato, 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
SUPPL GMP
The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
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 |
|---|---|---|---|
| 4/16/2025 | 54FCL02ALFALFA (HERBAL & BOTANICALS, NOT TEAS) | 3560SUPPL GMP | Division of Southeast Imports (DSEI) |
| 4/16/2025 | 36CYT99HONEY, N.E.C. | 3560SUPPL GMP | Division of Southeast Imports (DSEI) |
| 9/6/2022 | 54YEY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Mas Natural Salud y Bienestar, S. de R.L. de C.V.'s FDA import refusal history?
Mas Natural Salud y Bienestar, S. de R.L. de C.V. (FEI: 3010165400) has 3 FDA import refusal record(s) in our database, spanning from 9/6/2022 to 4/16/2025.
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. Mas Natural Salud y Bienestar, S. de R.L. de C.V.'s FEI number is 3010165400.
What types of violations has Mas Natural Salud y Bienestar, S. de R.L. de C.V. received?
Mas Natural Salud y Bienestar, S. de R.L. de C.V. has been cited for 2 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 Mas Natural Salud y Bienestar, S. de R.L. de C.V. come from?
All FDA import refusal data for Mas Natural Salud y Bienestar, S. de R.L. 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.