Apex Laboratories Private Ltd
⚠️ High Risk
FEI: 3011361515 • Alathur, Tamil Nadu • INDIA
FEI Number
3011361515
Location
Alathur, Tamil Nadu
Country
INDIAAddress
B23 Sidco Pharmaceutical Complex, Thiruporur, Alathur, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2025 | 54AGA03VITAMIN B2 (RIBOFLAVIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2025 | 54BFY13ZINC (MINERAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2024 | 61PCC99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2024 | 62VBY99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/28/2023 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2018 | 60YDA99INHIBITOR (GROWTH FACTOR) N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2004 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Apex Laboratories Private Ltd's FDA import refusal history?
Apex Laboratories Private Ltd (FEI: 3011361515) has 8 FDA import refusal record(s) in our database, spanning from 6/25/2004 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. Apex Laboratories Private Ltd's FEI number is 3011361515.
What types of violations has Apex Laboratories Private Ltd received?
Apex Laboratories Private 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 Apex Laboratories Private Ltd come from?
All FDA import refusal data for Apex Laboratories Private 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.