Disroga, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3003256429 • Nuevo Laredo, TAM • MEXICO
FEI Number
3003256429
Location
Nuevo Laredo, TAM
Country
MEXICOAddress
Coahuila No 3824 Col. Juarez, , Nuevo Laredo, TAM, 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
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).
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2003 | 33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Southwest Import District Office (SWI-DO) | |
| 7/15/2003 | 56DBJ41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | Southwest Import District Office (SWI-DO) | |
| 10/22/2002 | 29BCY99CARBONATED SOFT DRINK, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 8/6/2002 | 29BCY99CARBONATED SOFT DRINK, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Disroga, S.A. De C.V.'s FDA import refusal history?
Disroga, S.A. De C.V. (FEI: 3003256429) has 4 FDA import refusal record(s) in our database, spanning from 8/6/2002 to 12/8/2003.
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. Disroga, S.A. De C.V.'s FEI number is 3003256429.
What types of violations has Disroga, S.A. De C.V. received?
Disroga, 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 Disroga, S.A. De C.V. come from?
All FDA import refusal data for Disroga, 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.