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CONSUMER HEALTHCARE GSK

⚠️ Moderate Risk

FEI: 3023687077 • Philadelphia, PA • UNITED STATES

FEI

FEI Number

3023687077

📍

Location

Philadelphia, PA

🇺🇸
🏢

Address

2929 Walnut St Ste 1700, , Philadelphia, PA, United States

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
11/10/2025
Latest Refusal
12/22/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
96.2×20%
Frequency
10.6×10%
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

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).

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.

751×

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
11/10/2025
61XDY50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/22/2023
60SBA99ANTACID, N.E.C.
118NOT LISTED
336INCONSPICU
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is CONSUMER HEALTHCARE GSK's FDA import refusal history?

CONSUMER HEALTHCARE GSK (FEI: 3023687077) has 2 FDA import refusal record(s) in our database, spanning from 12/22/2023 to 11/10/2025.

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. CONSUMER HEALTHCARE GSK's FEI number is 3023687077.

What types of violations has CONSUMER HEALTHCARE GSK received?

CONSUMER HEALTHCARE GSK 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 CONSUMER HEALTHCARE GSK come from?

All FDA import refusal data for CONSUMER HEALTHCARE GSK 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.