Micro labs limited
⚠️ High Risk
FEI: 3010352162 • Dist Solan • INDIA
FEI Number
3010352162
Location
Dist Solan
Country
INDIAAddress
HB-211, Village Katha, , Tehsil Nalagarh, Dist Solan, , 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).
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 |
|---|---|---|---|
| 7/3/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2024 | 61XDY51LEVOCETIRIZINE DIHYDROCHLORIDE | Division of Southeast Imports (DSEI) | |
| 11/14/2024 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 1/4/2017 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/23/2016 | 61KDY05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/14/2014 | 61LCY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/13/2011 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Micro labs limited's FDA import refusal history?
Micro labs limited (FEI: 3010352162) has 7 FDA import refusal record(s) in our database, spanning from 9/13/2011 to 7/3/2025.
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 limited's FEI number is 3010352162.
What types of violations has Micro labs limited received?
Micro labs 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 Micro labs limited come from?
All FDA import refusal data for Micro labs 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.