WSI

⚠️ Moderate Risk

FEI: 3017590822 • Noida • INDIA

FEI

FEI Number

3017590822

📍

Location

Noida

🇮🇳

Country

INDIA

🏢

Address

A-36 Sector 60 Phase 3, , Noida, , India

Moderate Risk

FDA Import Risk Assessment

49.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/13/2023

Latest Refusal

12/1/2020

Earliest Refusal

Score Breakdown

Violation Severity

67.1×40%

Refusal Volume

38.6×30%

Recency

34.2×20%

Frequency

39.5×10%

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

Violation Summary

756×

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).

1184×

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).

32804×

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

Date	Product	Violations	Division
6/13/2023	60SCY99ANTACID, N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/13/2023	60SCY99ANTACID, N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/13/2023	62UCY99ANTI-TUSSIVE/COLD N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/13/2023	62UCY99ANTI-TUSSIVE/COLD N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
12/1/2020	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Southeast Imports (DSEI)
12/1/2020	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Southeast Imports (DSEI)
12/1/2020	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Southeast Imports (DSEI)
12/1/2020	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Southeast Imports (DSEI)
12/1/2020	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Southeast Imports (DSEI)
12/1/2020	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WSI's FDA import refusal history?

WSI (FEI: 3017590822) has 10 FDA import refusal record(s) in our database, spanning from 12/1/2020 to 6/13/2023.

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. WSI's FEI number is 3017590822.

What types of violations has WSI received?

WSI 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 WSI come from?

All FDA import refusal data for WSI 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.