Teva API India Private Ltd.
⚠️ Moderate Risk
FEI: 3005343793 • Amroha, Uttar Pradesh • INDIA
FEI Number
3005343793
Location
Amroha, Uttar Pradesh
Country
INDIAAddress
A2, A-2/1, A-2/2 Upsidc Ind. Area, Bijnor Road, Gajraula, Amroha, Uttar Pradesh, 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
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2019 | 62OCS24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/4/2019 | 62OCS24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/4/2019 | 62OCS24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/4/2019 | 62OCS24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/4/2019 | 62OCS24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/6/2017 | 61ECS09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 4/6/2017 | 61ECS09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 4/6/2017 | 61ECS09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 1/6/2012 | 64BCB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Teva API India Private Ltd.'s FDA import refusal history?
Teva API India Private Ltd. (FEI: 3005343793) has 9 FDA import refusal record(s) in our database, spanning from 1/6/2012 to 10/4/2019.
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. Teva API India Private Ltd.'s FEI number is 3005343793.
What types of violations has Teva API India Private Ltd. received?
Teva API India Private Ltd. has been cited for 3 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 Teva API India Private Ltd. come from?
All FDA import refusal data for Teva API India Private Ltd. 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.