Herbal Solution's Health S.A. de C.V.
⚠️ Moderate Risk
FEI: 3011478105 • Irapuato, Guanajuato • MEXICO
FEI Number
3011478105
Location
Irapuato, Guanajuato
Country
MEXICOAddress
Calzada Insurgentes Poniente No. 322, Barrio Barrio De Santa Anita, 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
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).
LIST INGRE
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)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
INCONSPICU
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/7/2023 | 31KHT99TEA, N.E.C. | Division of Southwest Imports (DSWI) | |
| 3/27/2020 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Division of Southwest Imports (DSWI) | |
| 10/25/2019 | 56GBL99ANTIFUNGAL N.E.C. | Division of Southwest Imports (DSWI) | |
| 7/23/2019 | 54FYY08ECHINACEA, HERBAL & BOTANICALS (NOT TEAS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 7/10/2019 | 54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Division of Southwest Imports (DSWI) |
| 7/27/2018 | 54FCZ84MILK THISTLE (HERBAL & BOTANICAL OTHER THAN TEAS) | 482NUTRIT LBL | Division of Southwest Imports (DSWI) |
| 7/25/2018 | 03HGT03OATMEAL PLAIN COOKIES,BISCUITS, AND WAFERS | 256INCONSPICU | Division of Southwest Imports (DSWI) |
| 7/25/2018 | 54FYA32ARNICA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Herbal Solution's Health S.A. de C.V.'s FDA import refusal history?
Herbal Solution's Health S.A. de C.V. (FEI: 3011478105) has 8 FDA import refusal record(s) in our database, spanning from 7/25/2018 to 8/7/2023.
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 Solution's Health S.A. de C.V.'s FEI number is 3011478105.
What types of violations has Herbal Solution's Health S.A. de C.V. received?
Herbal Solution's 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 Solution's Health S.A. de C.V. come from?
All FDA import refusal data for Herbal Solution's 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.