Fourrts (India) Laboratories Pvt. Limited
⚠️ Moderate Risk
FEI: 3004878724 • Kelambakkam, Tamil Nadu • INDIA
FEI Number
3004878724
Location
Kelambakkam, Tamil Nadu
Country
INDIAAddress
Vandalur Road, , Kelambakkam, Tamil Nadu, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2021 | 60SCK26SUCRALFATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2020 | 62UAA99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2019 | 60SCL26SUCRALFATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2018 | 60SDL99ANTACID, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Fourrts (India) Laboratories Pvt. Limited's FDA import refusal history?
Fourrts (India) Laboratories Pvt. Limited (FEI: 3004878724) has 4 FDA import refusal record(s) in our database, spanning from 2/28/2018 to 4/12/2021.
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 Pvt. Limited's FEI number is 3004878724.
What types of violations has Fourrts (India) Laboratories Pvt. Limited received?
Fourrts (India) Laboratories Pvt. 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 Fourrts (India) Laboratories Pvt. Limited come from?
All FDA import refusal data for Fourrts (India) Laboratories Pvt. 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.