MICRO LABS LIMITED
⚠️ High Risk
FEI: 3003960717 • Hosur, Tamil Nadu • INDIA
FEI Number
3003960717
Location
Hosur, Tamil Nadu
Country
INDIAAddress
92, SIPCOT Industrial Complex, , Hosur, Tamil Nadu, 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 |
|---|---|---|---|
| 9/29/2025 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Division of Southeast Imports (DSEI) | |
| 1/12/2022 | 61WDY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2020 | 62LDA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2017 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2017 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2016 | 61NCA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/2/2015 | 62GAY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 56ICY35ERYTHROMYCIN STEARATE (MACROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/11/2005 | 63BDA02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 62LDA50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 62GDA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 61WDB99A-FUNGAL N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is MICRO LABS LIMITED's FDA import refusal history?
MICRO LABS LIMITED (FEI: 3003960717) has 14 FDA import refusal record(s) in our database, spanning from 2/11/2005 to 9/29/2025.
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 3003960717.
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.