Intas Pharmaceuticals Limited
⚠️ High Risk
FEI: 3005354974 • Ahmedabad, Gujarat • INDIA
FEI Number
3005354974
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Premier House, 10th Floor, Sarkhej Gandhinagar Highway, Ahmedabad, Gujarat, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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 |
|---|---|---|---|
| 12/10/2025 | 63VDO02HYDROQUINONE (DEPIGMENTOR) | Division of Southeast Imports (DSEI) | |
| 4/11/2024 | 66NCA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/17/2022 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Intas Pharmaceuticals Limited's FDA import refusal history?
Intas Pharmaceuticals Limited (FEI: 3005354974) has 3 FDA import refusal record(s) in our database, spanning from 2/17/2022 to 12/10/2025.
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. Intas Pharmaceuticals Limited's FEI number is 3005354974.
What types of violations has Intas Pharmaceuticals Limited received?
Intas Pharmaceuticals Limited 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 Intas Pharmaceuticals Limited come from?
All FDA import refusal data for Intas Pharmaceuticals 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.