NATURAL PALACE S. A. DE C. V.
⚠️ Moderate Risk
FEI: 3007967170 • Irapuato, Guanajuato • MEXICO
FEI Number
3007967170
Location
Irapuato, Guanajuato
Country
MEXICOAddress
Manuel Doblado # 37, Zona Centro, 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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/8/2013 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/6/2012 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2012 | 41YHT99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2012 | 41YHT99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2012 | 41YHT99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/9/2010 | 54YCY01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 4/19/2010 | 54YCY01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Southwest Import District Office (SWI-DO) | |
| 4/19/2010 | 54YCY01SPIRULINA (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is NATURAL PALACE S. A. DE C. V.'s FDA import refusal history?
NATURAL PALACE S. A. DE C. V. (FEI: 3007967170) has 10 FDA import refusal record(s) in our database, spanning from 4/19/2010 to 5/8/2013.
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 PALACE S. A. DE C. V.'s FEI number is 3007967170.
What types of violations has NATURAL PALACE S. A. DE C. V. received?
NATURAL PALACE S. A. DE C. V. 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 NATURAL PALACE S. A. DE C. V. come from?
All FDA import refusal data for NATURAL PALACE 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.