Grupo Gamesa S.A. de C.V.
⚠️ Moderate Risk
FEI: 1000434588 • Sonora • MEXICO
FEI Number
1000434588
Location
Sonora
Country
MEXICOAddress
Blvd. Rofolfo Elias Calles Y Ave., , Obregon, Sonora, , 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)).
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/15/2010 | 03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 274COLOR LBLG | Southwest Import District Office (SWI-DO) |
| 11/15/2010 | 03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 274COLOR LBLG | Southwest Import District Office (SWI-DO) |
| 11/15/2010 | 03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 274COLOR LBLG | Southwest Import District Office (SWI-DO) |
| 7/27/2005 | 03JFT10CREME FILLED/ICED COOKIE,BISCUIT,WAFER | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03JFT07MIXED FILLED/ICED COOKIES,BISCUITS AND WAFERS | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03JFT07MIXED FILLED/ICED COOKIES,BISCUITS AND WAFERS | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03FHT06SALTED CRACKERS | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03JGT09FRUIT/FRUIT FLAVORED FILLED/ICED COOKIES,BISCUITS AND WAFERS | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03JGT01VANILLA FILLED/ICED COOKIES,BISCUITS AND WAFERS | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03HGT01VANILLA PLAIN COOKIE,BISCUIT AND WAFER | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03MGT06FRUIT FILLED COOKIE,BISCUIT,WAFER DOUGH | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03JGT10CREME FILLED/ICED COOKIE,BISCUIT,WAFER | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03MGT07MIXED COOKIE,BISCUIT,WAFER DOUGH | Southwest Import District Office (SWI-DO) | |
| 7/27/2005 | 03JFT02CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Grupo Gamesa S.A. de C.V.'s FDA import refusal history?
Grupo Gamesa S.A. de C.V. (FEI: 1000434588) has 14 FDA import refusal record(s) in our database, spanning from 7/27/2005 to 11/15/2010.
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. Grupo Gamesa S.A. de C.V.'s FEI number is 1000434588.
What types of violations has Grupo Gamesa S.A. de C.V. received?
Grupo Gamesa S.A. de C.V. has been cited for 4 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 Grupo Gamesa S.A. de C.V. come from?
All FDA import refusal data for Grupo Gamesa 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.