Microlabs Ltd
⚠️ High Risk
FEI: 3011697796 • Sikkim • INDIA
FEI Number
3011697796
Location
Sikkim
Country
INDIAAddress
Mamring Nathang Rd South, , Sikkim, , 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 | 60LCY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 62ODA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2023 | 60LDB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2021 | 61PDY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2021 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 62OCA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2019 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2019 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2017 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Microlabs Ltd's FDA import refusal history?
Microlabs Ltd (FEI: 3011697796) has 12 FDA import refusal record(s) in our database, spanning from 12/15/2017 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. Microlabs Ltd's FEI number is 3011697796.
What types of violations has Microlabs Ltd received?
Microlabs Ltd 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 Microlabs Ltd come from?
All FDA import refusal data for Microlabs 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.