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Your Chemist Shop P/L**

⚠️ High Risk

FEI: 3009956886 • Maroubra, Nsw • AUSTRALIA

FEI

FEI Number

3009956886

📍

Location

Maroubra, Nsw

🇦🇺

Country

AUSTRALIA
🏢

Address

Anzac Pde, , Maroubra, Nsw, Australia

High Risk

FDA Import Risk Assessment

54.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

8
Total Refusals
1
Unique Violations
11/29/2013
Latest Refusal
6/18/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

758×

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
11/29/2013
60WQY99ANTHELMINTIC, N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/13/2013
62SCY03AZELAIC ACID (ANTI-SEBORRHEIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/13/2013
62SCY03AZELAIC ACID (ANTI-SEBORRHEIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/13/2013
62SCY03AZELAIC ACID (ANTI-SEBORRHEIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
9/3/2013
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/15/2013
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/7/2013
66SCJ28NITROGLYCERIN (TAB) (VASODILATOR)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/18/2013
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Your Chemist Shop P/L**'s FDA import refusal history?

Your Chemist Shop P/L** (FEI: 3009956886) has 8 FDA import refusal record(s) in our database, spanning from 6/18/2013 to 11/29/2013.

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. Your Chemist Shop P/L**'s FEI number is 3009956886.

What types of violations has Your Chemist Shop P/L** received?

Your Chemist Shop P/L** 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 Your Chemist Shop P/L** come from?

All FDA import refusal data for Your Chemist Shop P/L** 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.