Fersinsa GB, SA de CV
⚠️ High Risk
FEI: 3000538793 • Ramos Arizpe, Coahuila • MEXICO
FEI Number
3000538793
Location
Ramos Arizpe, Coahuila
Country
MEXICOAddress
Camino A Guanajuato S/N, , Ramos Arizpe, Coahuila, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2024 | 56ACY99PENICILLIN NATURAL, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/16/2023 | 60HDT99ALDOSTERONE ANTAGONIST, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/6/2005 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2004 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/8/2004 | 56BBS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2004 | 56BBS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2002 | 56BBS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Fersinsa GB, SA de CV's FDA import refusal history?
Fersinsa GB, SA de CV (FEI: 3000538793) has 7 FDA import refusal record(s) in our database, spanning from 3/26/2002 to 6/13/2024.
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. Fersinsa GB, SA de CV's FEI number is 3000538793.
What types of violations has Fersinsa GB, SA de CV received?
Fersinsa GB, SA de CV has been cited for 4 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 Fersinsa GB, SA de CV come from?
All FDA import refusal data for Fersinsa 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.