PHARMETIQUE SA
⚠️ High Risk
FEI: 3012727775 • Bogota • COLOMBIA
FEI Number
3012727775
Location
Bogota
Country
COLOMBIAAddress
Carrera 65b NO 13-13, , Bogota, , 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2026 | 60LCL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/18/2024 | 62FDY34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 62UDB13HYDROCODONE BITARTRATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2020 | 60LCY01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/21/2020 | 61ECY08LORATADINE (ANTI-ASTHMATIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PHARMETIQUE SA's FDA import refusal history?
PHARMETIQUE SA (FEI: 3012727775) has 6 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. PHARMETIQUE SA's FEI number is 3012727775.
What types of violations has PHARMETIQUE SA received?
PHARMETIQUE SA has been cited for 2 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 PHARMETIQUE SA come from?
All FDA import refusal data for PHARMETIQUE SA 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.