Natural Health II S. A. de C.V.
⚠️ Moderate Risk
FEI: 3010786031 • Irapuato, Guanajuato • MEXICO
FEI Number
3010786031
Location
Irapuato, Guanajuato
Country
MEXICOAddress
Calle Avellano No. 697, Col. BAJADA DE SAN MARTIN, 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
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)).
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.
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
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).
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/5/2018 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 3/27/2018 | 54ABY99VITAMIN, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 7/1/2016 | 54KCT03VALERIAN (HERBAL & BOTANICALS, NOT TEAS II) | 262DIETARY | Division of Southwest Imports (DSWI) |
| 5/25/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Southwest Imports (DSWI) |
| 8/29/2014 | 66CBE99STOOL SOFTENER N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/19/2009 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | Southwest Import District Office (SWI-DO) | |
| 3/20/2006 | 54BCF01CALCIUM (MINERAL) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Natural Health II S. A. de C.V.'s FDA import refusal history?
Natural Health II S. A. de C.V. (FEI: 3010786031) has 7 FDA import refusal record(s) in our database, spanning from 3/20/2006 to 11/5/2018.
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. Natural Health II S. A. de C.V.'s FEI number is 3010786031.
What types of violations has Natural Health II S. A. de C.V. received?
Natural Health II 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 Natural Health II S. A. de C.V. come from?
All FDA import refusal data for Natural Health II 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.