Catalent Australia Pty Ltd
⚠️ Moderate Risk
FEI: 3004250913 • Braeside, Victoria • AUSTRALIA
FEI Number
3004250913
Location
Braeside, Victoria
Country
AUSTRALIAAddress
217-221 Governor Rd, , Braeside, Victoria, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2012 | 66YDL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/23/2012 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Chicago District Office (CHI-DO) | |
| 9/20/2010 | 54ACH99VITAMIN, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Catalent Australia Pty Ltd's FDA import refusal history?
Catalent Australia Pty Ltd (FEI: 3004250913) has 3 FDA import refusal record(s) in our database, spanning from 9/20/2010 to 5/3/2012.
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. Catalent Australia Pty Ltd's FEI number is 3004250913.
What types of violations has Catalent Australia Pty Ltd received?
Catalent Australia Pty Ltd has been cited for 4 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 Catalent Australia Pty Ltd come from?
All FDA import refusal data for Catalent Australia 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.