PRODUCTOS FARMACEUTICOS COLLINS
⚠️ Moderate Risk
FEI: 3013329493 • Zapopan, Jalisco • MEXICO
FEI Number
3013329493
Location
Zapopan, Jalisco
Country
MEXICOAddress
S.A. de C.V Av. Prolong, , Zapopan, Jalisco, Mexico
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 |
|---|---|---|---|
| 3/29/2019 | 62GDR50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2018 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2017 | 64LCA56PREDNISONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/7/2017 | 62KCE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Division of Southeast Imports (DSEI) | |
| 3/31/2017 | 60CCA46NAPHAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PRODUCTOS FARMACEUTICOS COLLINS's FDA import refusal history?
PRODUCTOS FARMACEUTICOS COLLINS (FEI: 3013329493) has 5 FDA import refusal record(s) in our database, spanning from 3/31/2017 to 3/29/2019.
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. PRODUCTOS FARMACEUTICOS COLLINS's FEI number is 3013329493.
What types of violations has PRODUCTOS FARMACEUTICOS COLLINS received?
PRODUCTOS FARMACEUTICOS COLLINS 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 PRODUCTOS FARMACEUTICOS COLLINS come from?
All FDA import refusal data for PRODUCTOS FARMACEUTICOS COLLINS 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.