Productos Farmaceuticos Collins, S.A. De C.V.
⚠️ High Risk
FEI: 3004506692 • Guadalajara, Jalisco • MEXICO
FEI Number
3004506692
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Calle Cipres No. 1677, Del Fresno, Guadalajara, Jalisco, 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2025 | 60LCC99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2024 | 64LDY56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 55FY99CAPSULE SHELL, N.E.C., PHARM NECESSITY - CAPSULE SHELL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/25/2017 | 61WDJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2017 | 62KCA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2009 | 56BIY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Productos Farmaceuticos Collins, S.A. De C.V.'s FDA import refusal history?
Productos Farmaceuticos Collins, S.A. De C.V. (FEI: 3004506692) has 7 FDA import refusal record(s) in our database, spanning from 12/7/2009 to 5/16/2025.
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.A. De C.V.'s FEI number is 3004506692.
What types of violations has Productos Farmaceuticos Collins, S.A. De C.V. received?
Productos Farmaceuticos Collins, S.A. De C.V. 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, S.A. De C.V. come from?
All FDA import refusal data for Productos Farmaceuticos Collins, S.A. De C.V. 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.