COASPHARMA S.A.S.
⚠️ High Risk
FEI: 3012391062 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3012391062
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Calle 18 28a 43, , Bogota, Cundinamarca, 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 |
|---|---|---|---|
| 1/15/2020 | 60SCY28RANITIDINE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2020 | 62LCY09TINIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2020 | 64LCY33FLUPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2020 | 66MCY83HYDROXYZINE HCL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2020 | 60SCF23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2020 | 60ZCY02ALBENDAZOLE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2020 | 60SCY99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 62LCB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2017 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2017 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is COASPHARMA S.A.S.'s FDA import refusal history?
COASPHARMA S.A.S. (FEI: 3012391062) has 10 FDA import refusal record(s) in our database, spanning from 8/22/2017 to 1/15/2020.
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. COASPHARMA S.A.S.'s FEI number is 3012391062.
What types of violations has COASPHARMA S.A.S. received?
COASPHARMA 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 COASPHARMA S.A.S. come from?
All FDA import refusal data for COASPHARMA 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.