FOURRTS INDIA LABORATORIES
⚠️ High Risk
FEI: 3013242651 • Chennai, Tamil Nadu • INDIA
FEI Number
3013242651
Location
Chennai, Tamil Nadu
Country
INDIAAddress
1 Fourrts Av, , Chennai, 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2025 | 65BDY01ACETYLCYSTEINE (MUCOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 64HDL02GUAIFENESIN (EXPECTORANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/30/2023 | 54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/24/2020 | 65BDH01ACETYLCYSTEINE (MUCOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FOURRTS INDIA LABORATORIES's FDA import refusal history?
FOURRTS INDIA LABORATORIES (FEI: 3013242651) has 4 FDA import refusal record(s) in our database, spanning from 11/24/2020 to 5/27/2025.
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. FOURRTS INDIA LABORATORIES's FEI number is 3013242651.
What types of violations has FOURRTS INDIA LABORATORIES received?
FOURRTS INDIA LABORATORIES 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 FOURRTS INDIA LABORATORIES come from?
All FDA import refusal data for FOURRTS INDIA LABORATORIES 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.