Intas Pharmaceuticals Limited
🚨 Critical Risk
FEI: 3003157498 • Ahmedabad, Gujarat • INDIA
FEI Number
3003157498
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi, Sarkhej-Bavla Highway, Taluka-Sanand, Matoda, Ahmedabad, Gujarat, India
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2025 | 61LDC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 12/12/2025 | 65CDY07LEVOCARNITINE (NUTRIENT/TONIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/14/2025 | 62TAA07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 10/7/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/18/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2025 | 61LDB99ANTI-COAGULANT, N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/16/2025 | 61NCY78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 63HCK10LACTULOSE (CATHARTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 61NCB71LITHIUM CITRATE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/20/2025 | 61SAY99ANTI-ECZEMATIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 60CDY46NAPHAZOLINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 1/31/2025 | 61MDA41VALPROIC ACID (ANTI-CONVULSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 63HCL10LACTULOSE (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2024 | 60LDC01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2024 | 62OCB37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 11/14/2024 | 62TDB07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2024 | 65QDA31CHLORZOXAZONE (RELAXANT) | Division of Southeast Imports (DSEI) | |
| 7/2/2024 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/17/2024 | 61NDC84DESVENLAFAXINE SUCCINATE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/9/2024 | 66NDY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/1/2024 | 63HDA10LACTULOSE (CATHARTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 3/21/2024 | 64UDA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/1/2024 | 62OCY43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/19/2024 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/19/2024 | 64TCO08TACROLIMUS (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/10/2024 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/10/2024 | 58DCZ99ANTINEOPLASTIC, NEC | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/10/2024 | 64TCO08TACROLIMUS (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/10/2024 | 61KCB34OXYBUTYNIN CHLORIDE (ANTI-CHOLINERGIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/10/2024 | 64TCO08TACROLIMUS (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 64TCO08TACROLIMUS (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 64TCO08TACROLIMUS (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 58DCZ99ANTINEOPLASTIC, NEC | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/14/2023 | 61XDY51LEVOCETIRIZINE DIHYDROCHLORIDE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/21/2023 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2019 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2019 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2017 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2016 | 65PDF03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/5/2016 | 61PCY31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/24/2014 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/26/2012 | 66NCA07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/15/2011 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Intas Pharmaceuticals Limited's FDA import refusal history?
Intas Pharmaceuticals Limited (FEI: 3003157498) has 52 FDA import refusal record(s) in our database, spanning from 4/15/2011 to 12/29/2025.
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 3003157498.
What types of violations has Intas Pharmaceuticals Limited received?
Intas Pharmaceuticals Limited 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 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.