Pasar Express Sa
⚠️ Moderate Risk
FEI: 3003903507 • Cali • COLOMBIA
FEI Number
3003903507
Location
Cali
Country
COLOMBIAAddress
Ed Puentes, Ave 2 Norte 3 75, Cali, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2003 | 61ECA99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 64UCB05CLAVULANATE POTASS./TICARCILLIN DISODIUM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/21/2003 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pasar Express Sa's FDA import refusal history?
Pasar Express Sa (FEI: 3003903507) has 4 FDA import refusal record(s) in our database, spanning from 4/21/2003 to 12/3/2003.
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. Pasar Express Sa's FEI number is 3003903507.
What types of violations has Pasar Express Sa received?
Pasar Express Sa 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 Pasar Express Sa come from?
All FDA import refusal data for Pasar Express 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.