Sanofi Aventis Consumer Healthcare
⚠️ Moderate Risk
FEI: 3009985715 • Virginia, Queensland • AUSTRALIA
FEI Number
3009985715
Location
Virginia, Queensland
Country
AUSTRALIAAddress
87 Yarraman Pl, , Virginia, Queensland, Australia
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
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).
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/21/2021 | 60MDY06CODEINE SULFATE (ANALGESIC, NARCOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2020 | 62FAY34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 12/7/2017 | 62FAO34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sanofi Aventis Consumer Healthcare's FDA import refusal history?
Sanofi Aventis Consumer Healthcare (FEI: 3009985715) has 3 FDA import refusal record(s) in our database, spanning from 12/7/2017 to 4/21/2021.
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 Consumer Healthcare's FEI number is 3009985715.
What types of violations has Sanofi Aventis Consumer Healthcare received?
Sanofi Aventis Consumer Healthcare has been cited for 5 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 Consumer Healthcare come from?
All FDA import refusal data for Sanofi Aventis Consumer Healthcare 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.