Alembic Pharmaceuticals Limited
⚠️ High Risk
FEI: 3003238213 • Vadodara, Gujarat • INDIA
FEI Number
3003238213
Location
Vadodara, Gujarat
Country
INDIAAddress
Alembic Road, Next To Bhailal Amin General Hospital, , Vadodara, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2022 | 60LCY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2021 | 56IDY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2015 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/22/2012 | 61NCZ80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/23/2009 | 62HCS03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/5/2009 | 56IDB76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/12/2008 | 56ICB35ERYTHROMYCIN STEARATE (MACROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/27/2002 | 65PIY02SILDENAFIL CITRATE (REGULATOR) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Alembic Pharmaceuticals Limited's FDA import refusal history?
Alembic Pharmaceuticals Limited (FEI: 3003238213) has 10 FDA import refusal record(s) in our database, spanning from 2/27/2002 to 6/23/2022.
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. Alembic Pharmaceuticals Limited's FEI number is 3003238213.
What types of violations has Alembic Pharmaceuticals Limited received?
Alembic Pharmaceuticals Limited has been cited for 2 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 Alembic Pharmaceuticals Limited come from?
All FDA import refusal data for Alembic 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.