ImportRefusal LogoImportRefusal

CENTURION REMEDIES PVT. LTD.

⚠️ Moderate Risk

FEI: 3016924734 • Vadodara, Gujarat • INDIA

FEI

FEI Number

3016924734

📍

Location

Vadodara, Gujarat

🇮🇳

Country

INDIA
🏢

Address

G - 5 F - 19 H - 10, , Vadodara, Gujarat, India

Moderate Risk

FDA Import Risk Assessment

46.8
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
2/8/2022
Latest Refusal
1/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
6.7×20%
Frequency
27.4×10%
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

753×

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

DateProductViolationsDivision
2/8/2022
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/7/2022
65PCA02SILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/5/2021
65PAA02SILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CENTURION REMEDIES PVT. LTD.'s FDA import refusal history?

CENTURION REMEDIES PVT. LTD. (FEI: 3016924734) has 3 FDA import refusal record(s) in our database, spanning from 1/5/2021 to 2/8/2022.

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 REMEDIES PVT. LTD.'s FEI number is 3016924734.

What types of violations has CENTURION REMEDIES PVT. LTD. received?

CENTURION REMEDIES 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 CENTURION REMEDIES PVT. LTD. come from?

All FDA import refusal data for CENTURION REMEDIES 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.