Centurion Laboratories Private Limited
⚠️ Moderate Risk
FEI: 3008342939 • Tal-Savli, Gujarat • INDIA
FEI Number
3008342939
Location
Tal-Savli, Gujarat
Country
INDIAAddress
P-2, GIDC, Biotechpark Manjusar, , Vadodara, Tal-Savli, Gujarat, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 8/11/2022 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/22/2021 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/4/2021 | 66MDY64TRIFLUOPERAZINE HCL (TRANQUILIZER) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/21/2016 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Centurion Laboratories Private Limited's FDA import refusal history?
Centurion Laboratories Private Limited (FEI: 3008342939) has 4 FDA import refusal record(s) in our database, spanning from 4/21/2016 to 8/11/2022.
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. Centurion Laboratories Private Limited's FEI number is 3008342939.
What types of violations has Centurion Laboratories Private Limited received?
Centurion Laboratories Private Limited has been cited for 2 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 Private Limited come from?
All FDA import refusal data for Centurion Laboratories Private 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.