Aventis Pharma Limited
⚠️ Moderate Risk
FEI: 3008722407 • Mumbai, Maharashtra • INDIA
FEI Number
3008722407
Location
Mumbai, Maharashtra
Country
INDIAAddress
54 - A Mathuradas Vasanji Road, , Mumbai, Maharashtra, India
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2016 | 61PCA07GLIBORNURIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/5/2016 | 64BCY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/5/2016 | 62OCY05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/24/2014 | 61PCY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/11/2014 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/12/2012 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/3/2011 | 64EDA02PANCREATIN (ENZYME) | New York District Office (NYK-DO) | |
| 12/7/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/15/2010 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 5/19/2010 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 324NO ENGLISH | New York District Office (NYK-DO) |
| 8/11/2006 | 61EBA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2005 | 61PBC26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 61PCY31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2005 | 61PCP99ANTI-DIABETIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/6/2005 | 62OCP28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/15/2004 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Aventis Pharma Limited's FDA import refusal history?
Aventis Pharma Limited (FEI: 3008722407) has 17 FDA import refusal record(s) in our database, spanning from 12/15/2004 to 7/1/2016.
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. Aventis Pharma Limited's FEI number is 3008722407.
What types of violations has Aventis Pharma Limited received?
Aventis Pharma Limited has been cited for 7 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 Aventis Pharma Limited come from?
All FDA import refusal data for Aventis Pharma Limited 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.