Unichem Laboratories Limited
⚠️ Moderate Risk
FEI: 3002808417 • Mumbai, Maharashtra • INDIA
FEI Number
3002808417
Location
Mumbai, Maharashtra
Country
INDIAAddress
Prabhat Estate, S V Road, Mumbai, Maharashtra, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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 |
|---|---|---|---|
| 10/18/2021 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2019 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/22/2019 | 61RAY11ACTIVATED CHARCOAL (ANTIDOTE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2019 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 61NDB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 10/12/2017 | 61NDB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 1/14/2015 | 62CDY68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/24/2014 | 62OCY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/19/2011 | 62CCC10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/18/2007 | 62TAA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 62YCR07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Unichem Laboratories Limited's FDA import refusal history?
Unichem Laboratories Limited (FEI: 3002808417) has 12 FDA import refusal record(s) in our database, spanning from 6/18/2004 to 10/18/2021.
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. Unichem Laboratories Limited's FEI number is 3002808417.
What types of violations has Unichem Laboratories Limited received?
Unichem Laboratories 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 Unichem Laboratories Limited come from?
All FDA import refusal data for Unichem 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.