Laurus Labs Limited
⚠️ High Risk
FEI: 3007083664 • Anikapalli District, Andhra Pradesh • INDIA
FEI Number
3007083664
Location
Anikapalli District, Andhra Pradesh
Country
INDIAAddress
Plot No 18, & 21 Jawaharlal Nehru Pharma City; Parawada Mandal, Anikapalli District, Andhra Pradesh, 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).
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2024 | 62VCA73DOLUTEGRAVIR SODIUM (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2024 | 62VCA32LAMIVUDINE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 62VDA15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 62VCA32LAMIVUDINE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 62VCA73DOLUTEGRAVIR SODIUM (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2013 | 60WCJ15HEXYLRESORCINOL (ANTHELMINTIC) | New Orleans District Office (NOL-DO) | |
| 10/16/2013 | 60WCJ15HEXYLRESORCINOL (ANTHELMINTIC) | New Orleans District Office (NOL-DO) | |
| 2/22/2012 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2200DIET INGRE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Laurus Labs Limited's FDA import refusal history?
Laurus Labs Limited (FEI: 3007083664) has 8 FDA import refusal record(s) in our database, spanning from 2/22/2012 to 4/3/2024.
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. Laurus Labs Limited's FEI number is 3007083664.
What types of violations has Laurus Labs Limited received?
Laurus Labs Limited has been cited for 3 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 Laurus Labs Limited come from?
All FDA import refusal data for Laurus 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.