IPCA LABORATORIES LIMITED
⚠️ High Risk
FEI: 3013629659 • BHARIKHOLA • INDIA
FEI Number
3013629659
Location
BHARIKHOLA
Country
INDIAAddress
393-394 MELLI JORETHANG, , BHARIKHOLA, , 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 |
|---|---|---|---|
| 11/13/2025 | 64UDA08DUTASTERIDE | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/25/2025 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2020 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2020 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2019 | 64BCC14CHLORTHALIDONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2018 | 64HCY01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is IPCA LABORATORIES LIMITED's FDA import refusal history?
IPCA LABORATORIES LIMITED (FEI: 3013629659) has 8 FDA import refusal record(s) in our database, spanning from 12/11/2018 to 11/13/2025.
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 3013629659.
What types of violations has IPCA LABORATORIES LIMITED received?
IPCA LABORATORIES LIMITED 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 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.