PRODUCTOS FARMACEUTICOS
⚠️ Moderate Risk
FEI: 3012404391 • Guadalajara • MEXICO
FEI Number
3012404391
Location
Guadalajara
Country
MEXICOAddress
Collins Sp de Cz Cipres, , Guadalajara, , 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 |
|---|---|---|---|
| 12/11/2018 | 62QDY07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2017 | 64LCB56PREDNISONE (GLUCOCORTICOID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/11/2017 | 61ADA08DIIODOHYDROXYQUIN (ANTI-AMEBIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2017 | 56YCA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is PRODUCTOS FARMACEUTICOS's FDA import refusal history?
PRODUCTOS FARMACEUTICOS (FEI: 3012404391) has 6 FDA import refusal record(s) in our database, spanning from 7/11/2016 to 12/11/2018.
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. PRODUCTOS FARMACEUTICOS's FEI number is 3012404391.
What types of violations has PRODUCTOS FARMACEUTICOS received?
PRODUCTOS FARMACEUTICOS 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 come from?
All FDA import refusal data for PRODUCTOS FARMACEUTICOS 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.