Herbal Solutions Health, S.A. de C.V
⚠️ Moderate Risk
FEI: 3006484715 • Irapuato, Guanajuato • MEXICO
FEI Number
3006484715
Location
Irapuato, Guanajuato
Country
MEXICOAddress
Guadalupe de Paso Blanco Lot. 10, , 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
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).
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
USUAL NAME
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
PLANT PART
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)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2017 | 54FCL08ECHINACEA, HERBAL & BOTANICALS (NOT TEAS) | Division of Southwest Imports (DSWI) | |
| 12/17/2015 | 54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/29/2015 | 54FCH69WHITE OAK BARK (HERBAL & BOTANICALS, NOT TEAS) | 249FILTHY | Division of Southwest Imports (DSWI) |
| 4/9/2015 | 54FBH42CASCANS (RHAMNUS), (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 10/24/2014 | 54GBH04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS) | 249FILTHY | Southwest Import District Office (SWI-DO) |
| 7/27/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 7/27/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/10/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 7/10/2008 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Herbal Solutions Health, S.A. de C.V's FDA import refusal history?
Herbal Solutions Health, S.A. de C.V (FEI: 3006484715) has 9 FDA import refusal record(s) in our database, spanning from 7/10/2008 to 11/29/2017.
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. Herbal Solutions Health, S.A. de C.V's FEI number is 3006484715.
What types of violations has Herbal Solutions Health, S.A. de C.V received?
Herbal Solutions Health, S.A. de C.V has been cited for 9 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 Herbal Solutions Health, S.A. de C.V come from?
All FDA import refusal data for Herbal Solutions Health, 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.