Tevapharm India Private Limited
⚠️ Moderate Risk
FEI: 3011994731 • Ahmedabad, Gujarat • INDIA
FEI Number
3011994731
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Sanand II Industrial Estate, SM-46, GIDC-Bhol Sanand, Ahmedabad, Gujarat, 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
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.
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 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.
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).
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.
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2024 | 66YDC99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/31/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 4/20/2018 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Division of Northern Border Imports (DNBI) | |
| 4/20/2018 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Division of Northern Border Imports (DNBI) | |
| 3/29/2018 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Division of Southwest Imports (DSWI) | |
| 5/26/2017 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Division of Northern Border Imports (DNBI) | |
| 1/4/2017 | 62MBK01CAMPHOR (ANTI-PRURITIC) | New Orleans District Office (NOL-DO) | |
| 9/13/2016 | 65SBJ99RUBEFACIENT N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/17/2016 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Tevapharm India Private Limited's FDA import refusal history?
Tevapharm India Private Limited (FEI: 3011994731) has 9 FDA import refusal record(s) in our database, spanning from 2/17/2016 to 8/22/2024.
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. Tevapharm India Private Limited's FEI number is 3011994731.
What types of violations has Tevapharm India Private Limited received?
Tevapharm India Private 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 Tevapharm India Private Limited come from?
All FDA import refusal data for Tevapharm India Private 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.