Systopic Laboratories Pvt. Ltd.
⚠️ High Risk
FEI: 3006084740 • Bangalore • INDIA
FEI Number
3006084740
Location
Bangalore
Country
INDIAAddress
9-D, Bommasandra Industrial Area, , Bangalore, , 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 |
|---|---|---|---|
| 4/4/2024 | 66VDE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Systopic Laboratories Pvt. Ltd.'s FDA import refusal history?
Systopic Laboratories Pvt. Ltd. (FEI: 3006084740) has 1 FDA import refusal record(s) in our database, spanning from 4/4/2024 to 4/4/2024.
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. Systopic Laboratories Pvt. Ltd.'s FEI number is 3006084740.
What types of violations has Systopic Laboratories Pvt. Ltd. received?
Systopic Laboratories Pvt. 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 Systopic Laboratories Pvt. Ltd. come from?
All FDA import refusal data for Systopic Laboratories Pvt. 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.