Lbc Express Inc.
⚠️ Moderate Risk
FEI: 3004916556 • Pasay City, National Capital Region • PHILIPPINES
FEI Number
3004916556
Location
Pasay City, National Capital Region
Country
PHILIPPINESAddress
Domestic Road, M.M., Pasay City, National Capital Region, 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).
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.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/31/2005 | 62OCA24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 1/25/2005 | 62UBK99ANTI-TUSSIVE/COLD N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Lbc Express Inc.'s FDA import refusal history?
Lbc Express Inc. (FEI: 3004916556) has 3 FDA import refusal record(s) in our database, spanning from 1/25/2005 to 3/31/2016.
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. Lbc Express Inc.'s FEI number is 3004916556.
What types of violations has Lbc Express Inc. received?
Lbc Express Inc. has been cited for 5 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 Lbc Express Inc. come from?
All FDA import refusal data for Lbc Express Inc. 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.