Pro-Ma Systems (Aust.) Pty. Ltd.
⚠️ Moderate Risk
FEI: 3010148617 • Helensvale, Queensland • AUSTRALIA
FEI Number
3010148617
Location
Helensvale, Queensland
Country
AUSTRALIAAddress
14 Kingston Dr, , Helensvale, Queensland, 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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/24/2013 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 12/24/2013 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/24/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/24/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/24/2013 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Pro-Ma Systems (Aust.) Pty. Ltd.'s FDA import refusal history?
Pro-Ma Systems (Aust.) Pty. Ltd. (FEI: 3010148617) has 5 FDA import refusal record(s) in our database, spanning from 12/24/2013 to 12/24/2013.
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. Pro-Ma Systems (Aust.) Pty. Ltd.'s FEI number is 3010148617.
What types of violations has Pro-Ma Systems (Aust.) Pty. Ltd. received?
Pro-Ma Systems (Aust.) 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 Pro-Ma Systems (Aust.) Pty. Ltd. come from?
All FDA import refusal data for Pro-Ma Systems (Aust.) 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.