PRODUCTOS GIZEH SA DE CV
⚠️ Moderate Risk
FEI: 3006624269 • Zapopan, Jalisco • MEXICO
FEI Number
3006624269
Location
Zapopan, Jalisco
Country
MEXICOAddress
Calle Eugenio Cuzin Paq Industrial Belenes 933, Parque Industrial Belenes Norte, Zapopan, Zapopan, Jalisco, 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).
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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)).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSM MISB
The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 5/2/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 4/29/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 9/2/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 9/2/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 9/2/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 9/2/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 62SBL99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is PRODUCTOS GIZEH SA DE CV's FDA import refusal history?
PRODUCTOS GIZEH SA DE CV (FEI: 3006624269) has 8 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 2/24/2012.
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. PRODUCTOS GIZEH SA DE CV's FEI number is 3006624269.
What types of violations has PRODUCTOS GIZEH SA DE CV received?
PRODUCTOS GIZEH SA DE CV 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 PRODUCTOS GIZEH SA DE CV come from?
All FDA import refusal data for PRODUCTOS GIZEH SA DE CV 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.