Ipca Laboratories Limited
⚠️ High Risk
FEI: 3005888508 • Mumbai, Maharashtra • INDIA
FEI Number
3005888508
Location
Mumbai, Maharashtra
Country
INDIAAddress
142 - Ab Kandivli, , Mumbai, Maharashtra, 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).
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 56IDA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2024 | 62GDY48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2023 | 62IDB32METHOTREXATE SODIUM (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2023 | 88PPMGENERAL PURPOSE REAGENT | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/11/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2022 | 54FGE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 62LDA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Northern Border Imports (DNBI) | |
| 11/16/2021 | 60ZDB15IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2020 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 61ADY04CHLOROQUINE (ANTI-AMEBIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2016 | 61TCA26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 3/9/2016 | 62GCY94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/11/2014 | 63XCY99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/4/2014 | 61TCS27ONDANSETRON HCL DIHYDRATE (ANTI-EMETIC/NAUSEANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ipca Laboratories Limited's FDA import refusal history?
Ipca Laboratories Limited (FEI: 3005888508) has 14 FDA import refusal record(s) in our database, spanning from 4/4/2014 to 9/24/2025.
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. Ipca Laboratories Limited's FEI number is 3005888508.
What types of violations has Ipca Laboratories Limited received?
Ipca Laboratories Limited has been cited for 5 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 Ipca Laboratories Limited come from?
All FDA import refusal data for Ipca Laboratories 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.