ESPECIALIDADES NUTRITION SA DE C
⚠️ High Risk
FEI: 3023330771 • Zapopan, Jalisco • MEXICO
FEI Number
3023330771
Location
Zapopan, Jalisco
Country
MEXICOAddress
Avenida Patria Jardi 288, Col. Jardines De La Patria, Zapopan, Zapopan, Jalisco, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NO ENGLISH
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)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2025 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/13/2025 | 54FCC99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2024 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 4/22/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 4/10/2024 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/21/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) | |
| 3/21/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) | |
| 3/21/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) | |
| 3/21/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) | |
| 3/21/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) | |
| 3/18/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 2/23/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/23/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of West Coast Imports (DWCI) |
| 12/21/2023 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ESPECIALIDADES NUTRITION SA DE C's FDA import refusal history?
ESPECIALIDADES NUTRITION SA DE C (FEI: 3023330771) has 17 FDA import refusal record(s) in our database, spanning from 12/21/2023 to 4/4/2025.
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. ESPECIALIDADES NUTRITION SA DE C's FEI number is 3023330771.
What types of violations has ESPECIALIDADES NUTRITION SA DE C received?
ESPECIALIDADES NUTRITION SA DE C 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 ESPECIALIDADES NUTRITION SA DE C come from?
All FDA import refusal data for ESPECIALIDADES NUTRITION SA DE C 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.