Solara Active Pharma Sciences Limited
⚠️ Moderate Risk
FEI: 3008252997 • New Mangalore, Karnataka • INDIA
FEI Number
3008252997
Location
New Mangalore, Karnataka
Country
INDIAAddress
Plot No # 120a & B, 120p & 121, Industrial Area, Baikampady, New Mangalore, Karnataka, 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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2022 | 60WQS99ANTHELMINTIC, N.E.C. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 10/25/2022 | 60WQS99ANTHELMINTIC, N.E.C. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 5/4/2018 | 65QCS29SUCCINYLCHOLINE CHLORIDE (RELAXANT) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 8/20/2015 | 62RSS11PRAZIQUANTEL (ANTI-SCHISTOSOMAL) | 72NEW VET DR | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Solara Active Pharma Sciences Limited's FDA import refusal history?
Solara Active Pharma Sciences Limited (FEI: 3008252997) has 4 FDA import refusal record(s) in our database, spanning from 8/20/2015 to 10/25/2022.
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. Solara Active Pharma Sciences Limited's FEI number is 3008252997.
What types of violations has Solara Active Pharma Sciences Limited received?
Solara Active Pharma Sciences 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 Solara Active Pharma Sciences Limited come from?
All FDA import refusal data for Solara Active Pharma Sciences 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.