GLORMED COLOMBIA S.A.
⚠️ Moderate Risk
FEI: 3006543087 • Cartagena • COLOMBIA
FEI Number
3006543087
Location
Cartagena
Country
COLOMBIAAddress
Mamonal Km. 9 Zona Franca, , Cartagena, , 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 8/23/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 8/23/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 8/23/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 8/23/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 8/12/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 4/17/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Florida District Office (FLA-DO) |
| 4/14/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 1/22/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 11/25/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GLORMED COLOMBIA S.A.'s FDA import refusal history?
GLORMED COLOMBIA S.A. (FEI: 3006543087) has 10 FDA import refusal record(s) in our database, spanning from 11/25/2008 to 1/5/2012.
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. GLORMED COLOMBIA S.A.'s FEI number is 3006543087.
What types of violations has GLORMED COLOMBIA S.A. received?
GLORMED COLOMBIA 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 GLORMED COLOMBIA S.A. come from?
All FDA import refusal data for GLORMED COLOMBIA 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.