Micro Labs Ltd
⚠️ High Risk
FEI: 3007177081 • Bangalore • INDIA
FEI Number
3007177081
Location
Bangalore
Country
INDIAAddress
27 Race Course Rd, , Bangalore, , 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 |
|---|---|---|---|
| 12/5/2025 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 61LDY01ACENOCOUMAROL (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2025 | 61WDO47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 60LCY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2024 | 62VCY99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2024 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2024 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 56MCY01AZTREONAM (BACTAM (B-LACTAM ANTIBIOTIC)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2020 | 61TDE31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2020 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2019 | 56CDA54CEFIXIME (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 62GDY42INDOMETHACIN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2018 | 61MCB06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Micro Labs Ltd's FDA import refusal history?
Micro Labs Ltd (FEI: 3007177081) has 17 FDA import refusal record(s) in our database, spanning from 3/19/2018 to 12/5/2025.
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. Micro Labs Ltd's FEI number is 3007177081.
What types of violations has Micro Labs Ltd received?
Micro Labs 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 Micro Labs Ltd come from?
All FDA import refusal data for Micro Labs 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.