Mas Natural Salud Y Bienestar
⚠️ Moderate Risk
FEI: 3007809851 • Irapuato, Guanajuato • MEXICO
FEI Number
3007809851
Location
Irapuato, Guanajuato
Country
MEXICOAddress
Calle Escuadron 201 24la Moderna, Col. Moderna, Irapuato, 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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
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 |
|---|---|---|---|
| 12/2/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 12/2/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 12/2/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 12/1/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 12/1/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 12/1/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 11/23/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 11/23/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 11/23/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 11/23/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Southwest Import District Office (SWI-DO) |
| 4/17/2014 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 3/2/2011 | 54YBF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/1/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 3/16/2010 | 54ICR99FIBER, N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/16/2010 | 54FCY50HAWTHORN (HERBAL & BOTANICALS, NOT TEAS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/16/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/16/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Mas Natural Salud Y Bienestar's FDA import refusal history?
Mas Natural Salud Y Bienestar (FEI: 3007809851) has 17 FDA import refusal record(s) in our database, spanning from 3/16/2010 to 12/2/2015.
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 FEI number is 3007809851.
What types of violations has Mas Natural Salud Y Bienestar received?
Mas Natural Salud Y Bienestar has been cited for 6 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 come from?
All FDA import refusal data for Mas Natural Salud Y Bienestar 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.