Kingsway Compounding Pharmacy
⚠️ Moderate Risk
FEI: 3009199539 • Brookvale, New South Wales • AUSTRALIA
FEI Number
3009199539
Location
Brookvale, New South Wales
Country
AUSTRALIAAddress
U 40 9 Powells Rd, , Brookvale, New South Wales, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2020 | 54AYY05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 54ADK10MECOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/5/2011 | 54AFP05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kingsway Compounding Pharmacy's FDA import refusal history?
Kingsway Compounding Pharmacy (FEI: 3009199539) has 4 FDA import refusal record(s) in our database, spanning from 12/5/2011 to 8/19/2020.
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. Kingsway Compounding Pharmacy's FEI number is 3009199539.
What types of violations has Kingsway Compounding Pharmacy received?
Kingsway Compounding Pharmacy has been cited for 2 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 Kingsway Compounding Pharmacy come from?
All FDA import refusal data for Kingsway Compounding Pharmacy 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.