Centurion Laboratories
⚠️ High Risk
FEI: 3008546425 • Gorwa, Baroda • INDIA
FEI Number
3008546425
Location
Gorwa, Baroda
Country
INDIAAddress
G/5 & G/6, Industrial Estate, , Gorwa, Baroda, 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 |
|---|---|---|---|
| 12/8/2025 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2022 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2018 | 61WCB46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2011 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Centurion Laboratories's FDA import refusal history?
Centurion Laboratories (FEI: 3008546425) has 5 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 12/8/2025.
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. Centurion Laboratories's FEI number is 3008546425.
What types of violations has Centurion Laboratories received?
Centurion Laboratories 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 Centurion Laboratories come from?
All FDA import refusal data for Centurion Laboratories 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.