Rompope Coronado Sa De C.V.
⚠️ Moderate Risk
FEI: 3011297957 • San Luis Potosi, San Luis Potosi • MEXICO
FEI Number
3011297957
Location
San Luis Potosi, San Luis Potosi
Country
MEXICOAddress
Calle Eje 104 No. 933-B, Fracc. Zona Industrial, San Luis Potosi, 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
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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)).
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/15/2015 | 09FYT19WHEY, CONDENSED, GOAT MILK | 324NO ENGLISH | Division of Southwest Imports (DSWI) |
| 12/3/2013 | 27YCB06PEPPER SAUCE (HOT, MILD, ETC.) | 83NO PROCESS | Southwest Import District Office (SWI-DO) |
| 10/8/2013 | 33TGT02CARAMEL TOPPING (TOPPING WITHOUT FRUIT, NUTS OR CHOCOLATE) | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 10/8/2013 | 33TGT02CARAMEL TOPPING (TOPPING WITHOUT FRUIT, NUTS OR CHOCOLATE) | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 10/8/2013 | 03RCT99SWEET GOODS WITHOUT CUSTARD OR CREAM FILLING, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 10/7/2013 | 33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) | Southwest Import District Office (SWI-DO) | |
| 4/3/2012 | 24FCE08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE) | 83NO PROCESS | Southwest Import District Office (SWI-DO) |
| 1/17/2006 | 03RFY99SWEET GOODS WITHOUT CUSTARD OR CREAM FILLING, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Rompope Coronado Sa De C.V.'s FDA import refusal history?
Rompope Coronado Sa De C.V. (FEI: 3011297957) has 8 FDA import refusal record(s) in our database, spanning from 1/17/2006 to 4/15/2015.
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. Rompope Coronado Sa De C.V.'s FEI number is 3011297957.
What types of violations has Rompope Coronado Sa De C.V. received?
Rompope Coronado Sa 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 Rompope Coronado Sa De C.V. come from?
All FDA import refusal data for Rompope Coronado Sa 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.