Topline International
⚠️ Moderate Risk
FEI: 3006210578 • Auckland • NEW ZEALAND
FEI Number
3006210578
Location
Auckland
Country
NEW ZEALANDAddress
36 Kitchener St Level 3, , Auckland, , New Zealand
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).
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.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2007 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/12/2007 | 65LBL99PROTECTANT N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/11/2007 | 54YCH06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | New Orleans District Office (NOL-DO) | |
| 7/11/2007 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 54YCH06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 65LBL99PROTECTANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 5/10/2007 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | New Orleans District Office (NOL-DO) | |
| 5/3/2007 | 54YYY06BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2007 | 61HBY99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2007 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2007 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2007 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2007 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2007 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/3/2007 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/1/2007 | 61HBY99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Topline International's FDA import refusal history?
Topline International (FEI: 3006210578) has 16 FDA import refusal record(s) in our database, spanning from 5/1/2007 to 7/31/2007.
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. Topline International's FEI number is 3006210578.
What types of violations has Topline International received?
Topline International has been cited for 10 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 Topline International come from?
All FDA import refusal data for Topline International 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.