AMERICAN GENERICS S.A.S.
⚠️ High Risk
FEI: 3013651112 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
3013651112
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Carrera 1 46 84, , Cali, Valle Del Cauca, Colombia
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 |
|---|---|---|---|
| 10/27/2025 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/8/2020 | 62OCY13VERAPAMIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/8/2020 | 62OCY13VERAPAMIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2020 | 62KDY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AMERICAN GENERICS S.A.S.'s FDA import refusal history?
AMERICAN GENERICS S.A.S. (FEI: 3013651112) has 5 FDA import refusal record(s) in our database, spanning from 7/1/2020 to 10/27/2025.
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. AMERICAN GENERICS S.A.S.'s FEI number is 3013651112.
What types of violations has AMERICAN GENERICS S.A.S. received?
AMERICAN GENERICS S.A.S. 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 AMERICAN GENERICS S.A.S. come from?
All FDA import refusal data for AMERICAN GENERICS S.A.S. 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.