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Centurion Remedies PVT. LTD.

⚠️ Moderate Risk

FEI: 3015531173 • Vadodara, Vadodara • INDIA

FEI

FEI Number

3015531173

📍

Location

Vadodara, Vadodara

🇮🇳

Country

INDIA
🏢

Address

G/5 & G/6 , Industrial Estate, , Gorwa, Vadodara, Vadodara, India

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
9/17/2025
Latest Refusal
12/16/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
79.3×20%
Frequency
4.2×10%
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

752×

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).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/17/2025
66SCA51TADALAFIL
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/16/2020
65PDB02SILDENAFIL CITRATE (REGULATOR)
118NOT LISTED
3280FRNMFGREG
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: 3015531173) has 2 FDA import refusal record(s) in our database, spanning from 12/16/2020 to 9/17/2025.

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 Remedies PVT. LTD.'s FEI number is 3015531173.

What types of violations has Centurion Remedies PVT. LTD. received?

Centurion Remedies PVT. LTD. has been cited for 3 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.