Uttam Laboratories
⚠️ High Risk
FEI: 3004655396 • Karnal, Haryana • INDIA
FEI Number
3004655396
Location
Karnal, Haryana
Country
INDIAAddress
817 A Sadar Bazaar, , Karnal, Haryana, 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 |
|---|---|---|---|
| 9/11/2025 | 62MDA01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 54KFA03VALERIAN (HERBAL & BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 54CGY14DL-METHIONINE (NOT FOR INFANT FOODS) (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 54FGA89TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 54FGA88GYMNEMA SYLVESTRE (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 54KFA21AMLA (HERBAL & BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Uttam Laboratories's FDA import refusal history?
Uttam Laboratories (FEI: 3004655396) has 7 FDA import refusal record(s) in our database, spanning from 9/11/2025 to 9/11/2025.
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. Uttam Laboratories's FEI number is 3004655396.
What types of violations has Uttam Laboratories received?
Uttam Laboratories 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 Uttam Laboratories come from?
All FDA import refusal data for Uttam Laboratories 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.