Sandoz Sa De C.V.
⚠️ High Risk
FEI: 3009145152 • Delegacion Coyoacan • MEXICO
FEI Number
3009145152
Location
Delegacion Coyoacan
Country
MEXICOAddress
La Candelaria No 186, Col. Atlantida, Delegacion Coyoacan, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 8/12/2025 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2024 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2021 | 62GDA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 65BCA01ACETYLCYSTEINE (MUCOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2020 | 56CCP70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 61HDA99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sandoz Sa De C.V.'s FDA import refusal history?
Sandoz Sa De C.V. (FEI: 3009145152) has 7 FDA import refusal record(s) in our database, spanning from 3/7/2018 to 8/12/2025.
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. Sandoz Sa De C.V.'s FEI number is 3009145152.
What types of violations has Sandoz Sa De C.V. received?
Sandoz Sa 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 Sandoz Sa De C.V. come from?
All FDA import refusal data for Sandoz 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.