Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V.
⚠️ Moderate Risk
FEI: 3002779991 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3002779991
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Manuel Avila Camacho No. 44-A, Col. Santa Maria Aztahuacan, Iztapalapa, Ciudad De Mexico, Ciudad de Mexico, 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).
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)).
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.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2017 | 36DGY99IMITATION SYRUPS, MOLASSES AND HONEY, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 11/28/2016 | 60LAY99ANALGESIC, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/2/2015 | 31PFT99TEA SUBSTITUTES, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/7/2013 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/7/2013 | 36DHY99IMITATION SYRUPS, MOLASSES AND HONEY, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/7/2013 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Southwest Import District Office (SWI-DO) | |
| 1/7/2013 | 33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Southwest Import District Office (SWI-DO) | |
| 2/8/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 2/2/2004 | 36DGT99IMITATION SYRUPS, MOLASSES AND HONEY, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V.'s FDA import refusal history?
Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V. (FEI: 3002779991) has 10 FDA import refusal record(s) in our database, spanning from 11/27/2001 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. Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V.'s FEI number is 3002779991.
What types of violations has Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V. received?
Distribuidora de Alimentos Naturales y Nutricionales 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 Distribuidora de Alimentos Naturales y Nutricionales S.A de C.V. come from?
All FDA import refusal data for Distribuidora de Alimentos Naturales y Nutricionales 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.