PRODUCTOS FARMACEUTICOS COLLINS
⚠️ High Risk
FEI: 3014680368 • Guadalajara • MEXICO
FEI Number
3014680368
Location
Guadalajara
Country
MEXICOAddress
1677 Col Delfresno 1a, , Guadalajara, , Mexico
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 |
|---|---|---|---|
| 1/18/2026 | 66GCY25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2024 | 61EDA08LORATADINE (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 7/15/2022 | 62VDY45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2022 | 60QCB40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2021 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2021 | 56ECA80TETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2020 | 64LCA06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2019 | 61FCY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2019 | 62FDA13FURAZOLIDONE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 60LDB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2018 | 56GCJ99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PRODUCTOS FARMACEUTICOS COLLINS's FDA import refusal history?
PRODUCTOS FARMACEUTICOS COLLINS (FEI: 3014680368) has 12 FDA import refusal record(s) in our database, spanning from 10/4/2018 to 1/18/2026.
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. PRODUCTOS FARMACEUTICOS COLLINS's FEI number is 3014680368.
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.