Johnson & Johnson Pacific Pty Ltd
⚠️ Moderate Risk
FEI: 2000007294 • Ultimo, New South Wales • AUSTRALIA
FEI Number
2000007294
Location
Ultimo, New South Wales
Country
AUSTRALIAAddress
Ultimo, 45 Jones St, Ultimo, 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).
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).
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 |
|---|---|---|---|
| 10/6/2020 | 62LDO52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | Division of Southeast Imports (DSEI) | |
| 7/24/2020 | 98NAA02NICOTINE GUM | Division of Northern Border Imports (DNBI) | |
| 8/8/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Johnson & Johnson Pacific Pty Ltd's FDA import refusal history?
Johnson & Johnson Pacific Pty Ltd (FEI: 2000007294) has 3 FDA import refusal record(s) in our database, spanning from 8/8/2016 to 10/6/2020.
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. Johnson & Johnson Pacific Pty Ltd's FEI number is 2000007294.
What types of violations has Johnson & Johnson Pacific Pty Ltd received?
Johnson & Johnson Pacific Pty Ltd 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 Johnson & Johnson Pacific Pty Ltd come from?
All FDA import refusal data for Johnson & Johnson Pacific Pty Ltd 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.