UNICHEM LABORATORIES LTD
⚠️ Moderate Risk
FEI: 3016887258 • Mumbai, Maharashtra • INDIA
FEI Number
3016887258
Location
Mumbai, Maharashtra
Country
INDIAAddress
Unichem Bhavan, , 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 |
|---|---|---|---|
| 4/1/2024 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 6/19/2020 | 64BAA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 64BAA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is UNICHEM LABORATORIES LTD's FDA import refusal history?
UNICHEM LABORATORIES LTD (FEI: 3016887258) has 3 FDA import refusal record(s) in our database, spanning from 6/19/2020 to 4/1/2024.
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. UNICHEM LABORATORIES LTD's FEI number is 3016887258.
What types of violations has UNICHEM LABORATORIES LTD received?
UNICHEM LABORATORIES LTD 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 LTD come from?
All FDA import refusal data for UNICHEM 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.