Premium Lab
⚠️ Moderate Risk
FEI: 3003795371 • Rizal • PHILIPPINES
FEI Number
3003795371
Location
Rizal
Country
PHILIPPINESAddress
498 M.H. Del Pilar St., , Rizal, , Philippines
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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2017 | 60WRA26PIPERAZINE (ANTHELMINTIC) | 72NEW VET DR | Seattle District Office (SEA-DO) |
| 12/5/2016 | 60WRA26PIPERAZINE (ANTHELMINTIC) | Seattle District Office (SEA-DO) | |
| 11/30/2016 | 60WRA26PIPERAZINE (ANTHELMINTIC) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Premium Lab's FDA import refusal history?
Premium Lab (FEI: 3003795371) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2016 to 2/23/2017.
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. Premium Lab's FEI number is 3003795371.
What types of violations has Premium Lab received?
Premium Lab 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 Premium Lab come from?
All FDA import refusal data for Premium Lab 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.