CARMEN MILAGROS BAEZ BERMUDEZ
⚠️ Moderate Risk
FEI: 3014241867 • Medellin, Antioquia • COLOMBIA
FEI Number
3014241867
Location
Medellin, Antioquia
Country
COLOMBIAAddress
Cra 84 3 84 - 80 Picacho Secto, , Medellin, Antioquia, Colombia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 4/9/2018 | 80FMFSYRINGE, PISTON | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/9/2018 | 64LCP03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2018 | 66SCB51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2018 | 62OCB20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2018 | 62FCK53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CARMEN MILAGROS BAEZ BERMUDEZ's FDA import refusal history?
CARMEN MILAGROS BAEZ BERMUDEZ (FEI: 3014241867) has 5 FDA import refusal record(s) in our database, spanning from 4/9/2018 to 4/9/2018.
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. CARMEN MILAGROS BAEZ BERMUDEZ's FEI number is 3014241867.
What types of violations has CARMEN MILAGROS BAEZ BERMUDEZ received?
CARMEN MILAGROS BAEZ BERMUDEZ 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 CARMEN MILAGROS BAEZ BERMUDEZ come from?
All FDA import refusal data for CARMEN MILAGROS BAEZ BERMUDEZ 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.