Sanofi Aventis De Panama S.A.
⚠️ High Risk
FEI: 3011333633 • Zona 11, Provincia de Panama • PANAMA
FEI
FEI Number
3011333633
📍
Location
Zona 11, Provincia de Panama
🇵🇦
Country
PANAMA🏢
Address
Calle 47 Y Avenida Aquilino De La, , Zona 11, Provincia de Panama, Panama
High Risk
FDA Import Risk Assessment
61.0
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
112
Total Refusals
2
Unique Violations
7/22/2016
Latest Refusal
2/24/2015
Earliest Refusal
Score Breakdown
Violation Severity
70.6×40%
Refusal Volume
76.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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
7574×
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).
11870×
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 |
|---|---|---|---|
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60LBK99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60SBL23METOCLOPRAMIDE (ANTACID) | Florida District Office (FLA-DO) | |
| 7/22/2016 | 60SBL23METOCLOPRAMIDE (ANTACID) | Florida District Office (FLA-DO) | |
| 7/22/2016 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | Florida District Office (FLA-DO) | |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PCB31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PCB31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61MBL30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61MBV41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61MBV41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61MBV41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 60WBC16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 62OBC05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61MBV41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/19/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 76NTORINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 65JBJ11ETHISTERONE (PROGESTIN) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 60SBL23METOCLOPRAMIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 60LBJ63SALICYLAMIDE (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 63EBK19AMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 60SBL23METOCLOPRAMIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61MBL30VALPROATE SODIUM (ANTI-CONVULSANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 60SBL23METOCLOPRAMIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61MBV41VALPROIC ACID (ANTI-CONVULSANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61MBV41VALPROIC ACID (ANTI-CONVULSANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61MBY41VALPROIC ACID (ANTI-CONVULSANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61MBY41VALPROIC ACID (ANTI-CONVULSANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61HBL43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 62OBC05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 60SBL23METOCLOPRAMIDE (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 65JBJ11ETHISTERONE (PROGESTIN) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61LBC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 62GBY99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Sanofi Aventis De Panama S.A.'s FDA import refusal history?
Sanofi Aventis De Panama S.A. (FEI: 3011333633) has 112 FDA import refusal record(s) in our database, spanning from 2/24/2015 to 7/22/2016.
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. Sanofi Aventis De Panama S.A.'s FEI number is 3011333633.
What types of violations has Sanofi Aventis De Panama S.A. received?
Sanofi Aventis De Panama S.A. 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 Sanofi Aventis De Panama S.A. come from?
All FDA import refusal data for Sanofi Aventis De Panama S.A. 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.