SYSTOPIC LABORATORIES PVT LTD
⚠️ Moderate Risk
FEI: 3012734640 • NEW DELHI • INDIA
FEI Number
3012734640
Location
NEW DELHI
Country
INDIAAddress
101 PRAGATI CHAMBERS CO, , NEW DELHI, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/15/2021 | 62OCA43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 60SDY27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2020 | 61TDE31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2020 | 61TDY31DOMPERIDONE | 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: 3012734640) has 5 FDA import refusal record(s) in our database, spanning from 7/28/2020 to 11/15/2021.
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. SYSTOPIC LABORATORIES PVT LTD's FEI number is 3012734640.
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.