PharmaCare Laboratories Pty Ltd
⚠️ Moderate Risk
FEI: 3007758694 • Warriewood, New South Wales • AUSTRALIA
FEI Number
3007758694
Location
Warriewood, New South Wales
Country
AUSTRALIAAddress
Warriewood, NSW, 18 Jubilee Ave, Warriewood, 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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
NCONTACTS
The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2020 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 3/24/2020 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 3/24/2020 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 11/21/2014 | 54EBA56RED CLOVER (HERBAL & BOTANICAL TEAS) | New Orleans District Office (NOL-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) | |
| 5/22/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is PharmaCare Laboratories Pty Ltd's FDA import refusal history?
PharmaCare Laboratories Pty Ltd (FEI: 3007758694) has 12 FDA import refusal record(s) in our database, spanning from 5/22/2009 to 3/24/2020.
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. PharmaCare Laboratories Pty Ltd's FEI number is 3007758694.
What types of violations has PharmaCare Laboratories Pty Ltd received?
PharmaCare Laboratories 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 PharmaCare Laboratories Pty Ltd come from?
All FDA import refusal data for PharmaCare Laboratories 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.