Micro Labs Limited - Unit III
⚠️ High Risk
FEI: 3004515884 • Puducherry • INDIA
FEI Number
3004515884
Location
Puducherry
Country
INDIAAddress
R.S. No.63/3 & 4, Thiruvandar Koil, Mannadipet Commune, Puducherry, , 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 |
|---|---|---|---|
| 9/21/2022 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/21/2022 | 62TDE06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2015 | 61MCE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/14/2012 | 61PDA31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/19/2009 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2007 | 62OCB12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2007 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Micro Labs Limited - Unit III's FDA import refusal history?
Micro Labs Limited - Unit III (FEI: 3004515884) has 7 FDA import refusal record(s) in our database, spanning from 6/17/2007 to 9/21/2022.
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 - Unit III's FEI number is 3004515884.
What types of violations has Micro Labs Limited - Unit III received?
Micro Labs Limited - Unit III 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 Limited - Unit III come from?
All FDA import refusal data for Micro Labs Limited - Unit III 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.