Integria Healthcare (Warwick) Pty Ltd
⚠️ Moderate Risk
FEI: 3007676042 • Brisbane, Queensland • AUSTRALIA
FEI Number
3007676042
Location
Brisbane, Queensland
Country
AUSTRALIAAddress
Building 5, 2728 Logan Road, Eight Mile Plains, Brisbane, 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
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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).
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2021 | 64XAJ99KERATOLYTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/12/2021 | 61HAL99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/12/2021 | 61HAL99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/12/2021 | 61HAL99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 1/3/2017 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 12/20/2016 | 61HBJ99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/17/2013 | 54FCA08ECHINACEA, HERBAL & BOTANICALS (NOT TEAS) | 3721PESTICIDE2 | Chicago District Office (CHI-DO) |
| 4/5/2010 | 54FBL08ECHINACEA, HERBAL & BOTANICALS (NOT TEAS) | 2920PESTICIDES | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Integria Healthcare (Warwick) Pty Ltd's FDA import refusal history?
Integria Healthcare (Warwick) Pty Ltd (FEI: 3007676042) has 8 FDA import refusal record(s) in our database, spanning from 4/5/2010 to 7/12/2021.
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. Integria Healthcare (Warwick) Pty Ltd's FEI number is 3007676042.
What types of violations has Integria Healthcare (Warwick) Pty Ltd received?
Integria Healthcare (Warwick) Pty Ltd has been cited for 6 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 Integria Healthcare (Warwick) Pty Ltd come from?
All FDA import refusal data for Integria Healthcare (Warwick) 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.