Maxima Distincion S.A De C.V
⚠️ Moderate Risk
FEI: 3005666129 • San Pedro Garza Garcia, Nuevo Leon • MEXICO
FEI Number
3005666129
Location
San Pedro Garza Garcia, Nuevo Leon
Country
MEXICOAddress
Calz. Del Valle 472 Ote., Col. DEL VALLE, San Pedro Garza Garcia, Nuevo Leon, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2010 | 62KCH10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/13/2010 | 64LCK03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/13/2010 | 60LCH83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Maxima Distincion S.A De C.V's FDA import refusal history?
Maxima Distincion S.A De C.V (FEI: 3005666129) has 3 FDA import refusal record(s) in our database, spanning from 12/13/2010 to 12/13/2010.
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. Maxima Distincion S.A De C.V's FEI number is 3005666129.
What types of violations has Maxima Distincion S.A De C.V received?
Maxima Distincion S.A De C.V has been cited for 1 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 Maxima Distincion S.A De C.V come from?
All FDA import refusal data for Maxima Distincion 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.