Intas Pharmaceuticals Limited
⚠️ High Risk
FEI: 3000978756 • Ahmedabad, Gujarat • INDIA
FEI Number
3000978756
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Plot 255, Magnet Corporate Park, Near sola bridge, S.G. Highway, Thaltej, 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
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).
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2025 | 60CDA02DOPAMINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2025 | 61TCA37AMISULPRIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2025 | 56YCS99ANTIBIOTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/16/2024 | 66NDA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2024 | 66NCY04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | Division of Southeast Imports (DSEI) | |
| 3/8/2024 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2024 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2023 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2023 | 61MAY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2023 | 61MAY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2023 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/17/2023 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/11/2023 | 61HCY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2022 | 61NDB99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2022 | 65QCY31CHLORZOXAZONE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2022 | 64LCY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2021 | 65QDA31CHLORZOXAZONE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2021 | 56CCA54CEFIXIME (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 61NDY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2021 | 63EDY13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2021 | 61NCY80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2019 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2018 | 64XCY11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/19/2017 | 61NCA83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2016 | 64XDF11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2011 | 61BCA04BICALUTAMIDE (ANTI-ANDROGEN) | 186INSANITARY | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Intas Pharmaceuticals Limited's FDA import refusal history?
Intas Pharmaceuticals Limited (FEI: 3000978756) has 26 FDA import refusal record(s) in our database, spanning from 2/15/2011 to 3/31/2025.
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 3000978756.
What types of violations has Intas Pharmaceuticals Limited received?
Intas Pharmaceuticals Limited has been cited for 4 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.