Trilogy
⚠️ Moderate Risk
FEI: 3005168915 • Wellington • NEW ZEALAND
FEI Number
3005168915
Location
Wellington
Country
NEW ZEALANDAddress
356 Thorndonp.O. Box 12, , Wellington, , 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/13/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 483DRUG NAME | Florida District Office (FLA-DO) |
| 5/29/2013 | 66PBL08PADIMATE A (ULTRAVIOLET SCREEN/SUNSCREEN) | Florida District Office (FLA-DO) | |
| 5/29/2013 | 66PBL08PADIMATE A (ULTRAVIOLET SCREEN/SUNSCREEN) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Trilogy's FDA import refusal history?
Trilogy (FEI: 3005168915) has 3 FDA import refusal record(s) in our database, spanning from 5/29/2013 to 5/13/2014.
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. Trilogy's FEI number is 3005168915.
What types of violations has Trilogy received?
Trilogy has been cited for 3 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 Trilogy come from?
All FDA import refusal data for Trilogy 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.