Ferinsa Gb Sa De Cv
⚠️ High Risk
FEI: 3003778564 • Ramos Arizpe, COA • MEXICO
FEI Number
3003778564
Location
Ramos Arizpe, COA
Country
MEXICOAddress
Carretera Saltillo-Monterrey Km 12.5, , Ramos Arizpe, COA, 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).
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 |
|---|---|---|---|
| 3/9/2015 | 56BYR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Florida District Office (FLA-DO) | |
| 1/5/2010 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/24/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/22/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/22/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/12/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/1/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/16/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/11/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/30/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/15/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/9/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/10/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/29/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/10/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/17/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Florida District Office (FLA-DO) | |
| 8/17/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Florida District Office (FLA-DO) | |
| 7/22/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/14/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/14/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/4/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/4/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/27/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/12/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/27/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/22/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/22/2004 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/19/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/5/2003 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/5/2003 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/23/2002 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/11/2002 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ferinsa Gb Sa De Cv's FDA import refusal history?
Ferinsa Gb Sa De Cv (FEI: 3003778564) has 35 FDA import refusal record(s) in our database, spanning from 9/11/2002 to 3/9/2015.
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. Ferinsa Gb Sa De Cv's FEI number is 3003778564.
What types of violations has Ferinsa Gb Sa De Cv received?
Ferinsa Gb Sa De Cv has been cited for 3 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 Ferinsa Gb Sa De Cv come from?
All FDA import refusal data for Ferinsa Gb 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.