Kassuri Limited - Rosa Maria Castillo Uribe
⚠️ Moderate Risk
FEI: 3008082890 • San Nicolas De La Garza • MEXICO
FEI Number
3008082890
Location
San Nicolas De La Garza
Country
MEXICOAddress
Av. Benito Juarez No. 404 Centro, , San Nicolas De La Garza, , 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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2017 | 41GGT99MEDICAL FOODS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2017 | 41GGT99MEDICAL FOODS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2010 | 61HAL99ANTI-BACTERIAL, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/5/2010 | 61HAL99ANTI-BACTERIAL, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/5/2010 | 54YGT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Kassuri Limited - Rosa Maria Castillo Uribe's FDA import refusal history?
Kassuri Limited - Rosa Maria Castillo Uribe (FEI: 3008082890) has 5 FDA import refusal record(s) in our database, spanning from 5/5/2010 to 3/16/2017.
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. Kassuri Limited - Rosa Maria Castillo Uribe's FEI number is 3008082890.
What types of violations has Kassuri Limited - Rosa Maria Castillo Uribe received?
Kassuri Limited - Rosa Maria Castillo Uribe has been cited for 3 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 Kassuri Limited - Rosa Maria Castillo Uribe come from?
All FDA import refusal data for Kassuri Limited - Rosa Maria Castillo Uribe 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.