API-ROYAL, S.A DE CV
⚠️ Moderate Risk
FEI: 2000006774 • San Luis Potosi, San Luis Potosi • MEXICO
FEI Number
2000006774
Location
San Luis Potosi, San Luis Potosi
Country
MEXICOAddress
Calle 7a Altos #237, Col. San Luis, 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
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2006 | 54ICR99FIBER, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/15/2006 | 54ICR99FIBER, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/15/2006 | 54ICR99FIBER, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/15/2006 | 54ICR99FIBER, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 3/20/2006 | 54ICR99FIBER, N.E.C. | 249FILTHY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is API-ROYAL, S.A DE CV's FDA import refusal history?
API-ROYAL, S.A DE CV (FEI: 2000006774) has 5 FDA import refusal record(s) in our database, spanning from 3/20/2006 to 5/15/2006.
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. API-ROYAL, S.A DE CV's FEI number is 2000006774.
What types of violations has API-ROYAL, S.A DE CV received?
API-ROYAL, S.A DE CV 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 API-ROYAL, S.A DE CV come from?
All FDA import refusal data for API-ROYAL, S.A 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.