El Poder De La Herbolaria S De Rl
⚠️ Moderate Risk
FEI: 3011926831 • Guadalajara, Jalisco • MEXICO
FEI Number
3011926831
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Calle Pablo Valdez 3316-Ahermosa, Col. LAGOS DE ORIENTE, Guadalajara, 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
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.
DIETARYING
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)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
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).
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.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2016 | 54IYR99FIBER, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/19/2016 | 54ECL99HERBALS & BOTANICAL TEAS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/19/2016 | 54ECL99HERBALS & BOTANICAL TEAS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/19/2016 | 54YCH01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Southwest Import District Office (SWI-DO) | |
| 2/19/2016 | 54ICH99FIBER, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/19/2016 | 54ICH99FIBER, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/19/2016 | 41YHT99DIETARY CONVENTIONAL FOODS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/19/2016 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is El Poder De La Herbolaria S De Rl's FDA import refusal history?
El Poder De La Herbolaria S De Rl (FEI: 3011926831) has 8 FDA import refusal record(s) in our database, spanning from 2/19/2016 to 2/19/2016.
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. El Poder De La Herbolaria S De Rl's FEI number is 3011926831.
What types of violations has El Poder De La Herbolaria S De Rl received?
El Poder De La Herbolaria S De Rl 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 El Poder De La Herbolaria S De Rl come from?
All FDA import refusal data for El Poder De La Herbolaria S De Rl 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.