Ipca Laboratories Ltd
⚠️ High Risk
FEI: 3010070496 • Mumbai, Maharashtra • INDIA
FEI Number
3010070496
Location
Mumbai, Maharashtra
Country
INDIAAddress
48 Kandivli Ind Estate, International House, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2024 | 60LDY69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 62ODY40LISINOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2021 | 60ZCY32PYRANTEL PAMOATE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2021 | 62LCY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2021 | 62LDA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2020 | 62LCY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/27/2020 | 60XCY17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/4/2020 | 62LDY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 61ADA04CHLOROQUINE (ANTI-AMEBIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 61ACY04CHLOROQUINE (ANTI-AMEBIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2020 | 61ADY06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/6/2017 | 61JDA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2005 | 60XBC17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2005 | 61PBC26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ipca Laboratories Ltd's FDA import refusal history?
Ipca Laboratories Ltd (FEI: 3010070496) has 14 FDA import refusal record(s) in our database, spanning from 11/22/2005 to 12/5/2024.
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 Ltd's FEI number is 3010070496.
What types of violations has Ipca Laboratories Ltd received?
Ipca Laboratories Ltd has been cited for 1 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 Ltd come from?
All FDA import refusal data for Ipca Laboratories 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.