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S5 TRADERS

Low Risk

FEI: 3015311435 • Tirupathi • INDIA

FEI

FEI Number

3015311435

📍

Location

Tirupathi

🇮🇳

Country

INDIA
🏢

Address

3rd Floor Padmavathi Pu, , Tirupathi, , India

Low Risk

FDA Import Risk Assessment

21.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
5
Unique Violations
6/28/2019
Latest Refusal
6/28/2019
Earliest Refusal

Score Breakdown

Violation Severity
44.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
6/28/2019
62FAZ99ANTI-INFECTIVE, TOPICAL N.E.C.
16DIRECTIONS
333LACKS FIRM
335LACKS N/C
336INCONSPICU
483DRUG NAME
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is S5 TRADERS's FDA import refusal history?

S5 TRADERS (FEI: 3015311435) has 1 FDA import refusal record(s) in our database, spanning from 6/28/2019 to 6/28/2019.

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. S5 TRADERS's FEI number is 3015311435.

What types of violations has S5 TRADERS received?

S5 TRADERS has been cited for 5 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 S5 TRADERS come from?

All FDA import refusal data for S5 TRADERS 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.