Lelalee Pharmaceutica Laboratori
⚠️ Moderate Risk
FEI: 3008408357 • Quezon City • PHILIPPINES
FEI Number
3008408357
Location
Quezon City
Country
PHILIPPINESAddress
None, , Quezon City, , 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
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
Frequently Asked Questions
What is Lelalee Pharmaceutica Laboratori's FDA import refusal history?
Lelalee Pharmaceutica Laboratori (FEI: 3008408357) has 2 FDA import refusal record(s) in our database, spanning from 7/26/2010 to 7/26/2010.
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. Lelalee Pharmaceutica Laboratori's FEI number is 3008408357.
What types of violations has Lelalee Pharmaceutica Laboratori received?
Lelalee Pharmaceutica Laboratori 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 Lelalee Pharmaceutica Laboratori come from?
All FDA import refusal data for Lelalee Pharmaceutica Laboratori 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.