ACCORD FARMA SA DE CV
⚠️ Moderate Risk
FEI: 3012733189 • DELEG GUSTAVO A • MEXICO
FEI Number
3012733189
Location
DELEG GUSTAVO A
Country
MEXICOAddress
MOCTEZUMA 123, , DELEG GUSTAVO A, , 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 |
|---|---|---|---|
| 2/15/2024 | 61PCC26METFORMIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/2/2017 | 61FDY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ACCORD FARMA SA DE CV's FDA import refusal history?
ACCORD FARMA SA DE CV (FEI: 3012733189) has 3 FDA import refusal record(s) in our database, spanning from 11/2/2017 to 2/15/2024.
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. ACCORD FARMA SA DE CV's FEI number is 3012733189.
What types of violations has ACCORD FARMA SA DE CV received?
ACCORD FARMA 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 ACCORD FARMA SA DE CV come from?
All FDA import refusal data for ACCORD FARMA 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.