Productos Farm. Collins, Sa De Cv
⚠️ Moderate Risk
FEI: 1000400803 • Guadalajara, Jalisco • MEXICO
FEI Number
1000400803
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Calle Cipres No. 1677, Fracc. Del Fresno, Guadalajara, Guadalajara, 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 |
|---|---|---|---|
| 3/17/2016 | 62KCA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2016 | 56BYB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 12/7/2011 | 62GCH99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 62QCB07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/22/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/19/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/22/2002 | 62LCJ52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Productos Farm. Collins, Sa De Cv's FDA import refusal history?
Productos Farm. Collins, Sa De Cv (FEI: 1000400803) has 7 FDA import refusal record(s) in our database, spanning from 10/22/2002 to 3/17/2016.
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 Farm. Collins, Sa De Cv's FEI number is 1000400803.
What types of violations has Productos Farm. Collins, Sa De Cv received?
Productos Farm. Collins, Sa De Cv 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 Farm. Collins, Sa De Cv come from?
All FDA import refusal data for Productos Farm. Collins, Sa De Cv 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.