Comercilizadora Breyti Diana Munoz Narvaez
⚠️ Moderate Risk
FEI: 3008077776 • San Luis Potosi, San Luis Potosi • MEXICO
FEI Number
3008077776
Location
San Luis Potosi, San Luis Potosi
Country
MEXICOAddress
Mariano Esparza No. 102, Col. SAN LEONEL, San Luis Potosi, San Luis Potosi, 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
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each 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.
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.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2010 | 54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 8/30/2010 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 5/12/2010 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/12/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 3/9/2010 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/9/2010 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Comercilizadora Breyti Diana Munoz Narvaez's FDA import refusal history?
Comercilizadora Breyti Diana Munoz Narvaez (FEI: 3008077776) has 6 FDA import refusal record(s) in our database, spanning from 3/9/2010 to 8/30/2010.
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. Comercilizadora Breyti Diana Munoz Narvaez's FEI number is 3008077776.
What types of violations has Comercilizadora Breyti Diana Munoz Narvaez received?
Comercilizadora Breyti Diana Munoz Narvaez has been cited for 7 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 Comercilizadora Breyti Diana Munoz Narvaez come from?
All FDA import refusal data for Comercilizadora Breyti Diana Munoz Narvaez 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.