Lite Express
⚠️ Moderate Risk
FEI: 3005015516 • San Juan • PHILIPPINES
FEI Number
3005015516
Location
San Juan
Country
PHILIPPINESAddress
34 Wilson St, , San Juan, , 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2005 | 60CBO46NAPHAZOLINE HCL (ADRENERGIC) | San Francisco District Office (SAN-DO) | |
| 10/21/2005 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/21/2005 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Lite Express's FDA import refusal history?
Lite Express (FEI: 3005015516) has 3 FDA import refusal record(s) in our database, spanning from 10/21/2005 to 10/21/2005.
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. Lite Express's FEI number is 3005015516.
What types of violations has Lite Express received?
Lite Express has been cited for 2 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 Lite Express come from?
All FDA import refusal data for Lite Express 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.