Tecnoquimicas S.A.
⚠️ High Risk
FEI: 3011268339 • Cali, FN • COLOMBIA
FEI Number
3011268339
Location
Cali, FN
Country
COLOMBIAAddress
Calle 23, No 7-34 San Nicolas, , Cali, FN, 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 |
|---|---|---|---|
| 1/6/2026 | 62GCY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 65QCE41FLAVOXATE HCL (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2023 | 61NDA76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2023 | 61NCA76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 61NDY76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/30/2021 | 56OCK02MOXIFLOXACIN HCL (FLUOROQUINOLONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2021 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2020 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2020 | 64SDY29ZOPICLONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2020 | 61FCY55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2020 | 62KDY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tecnoquimicas S.A.'s FDA import refusal history?
Tecnoquimicas S.A. (FEI: 3011268339) has 12 FDA import refusal record(s) in our database, spanning from 1/21/2020 to 1/6/2026.
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. Tecnoquimicas S.A.'s FEI number is 3011268339.
What types of violations has Tecnoquimicas S.A. received?
Tecnoquimicas S.A. 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 Tecnoquimicas S.A. come from?
All FDA import refusal data for Tecnoquimicas S.A. 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.