Lorenzana Food International
⚠️ High Risk
FEI: 3008341023 • Manila, National Capital Region • PHILIPPINES
FEI Number
3008341023
Location
Manila, National Capital Region
Country
PHILIPPINESAddress
Unit 28, 300 Legaspi, Barangay 658; Towers, Manila, National Capital Region, Philippines
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2016 | 31ADT03COFFEE, INSTANT | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/18/2016 | 31ADT03COFFEE, INSTANT | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/25/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 21VDI15MANGOSTEEN, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 31ADT03COFFEE, INSTANT | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 31ADT03COFFEE, INSTANT | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 31ADT03COFFEE, INSTANT | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/17/2013 | 31ADT03COFFEE, INSTANT | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/9/2013 | 31ADT03COFFEE, INSTANT | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 7/6/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 66VBI99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 66VBT99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 66VBU99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 21VDH15MANGOSTEEN, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 21VDH15MANGOSTEEN, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 31ADH03COFFEE, INSTANT | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 31ADH03COFFEE, INSTANT | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 31ADH03COFFEE, INSTANT | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/6/2012 | 60LBY99ANALGESIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/5/2010 | 31AGT03COFFEE, INSTANT | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Lorenzana Food International's FDA import refusal history?
Lorenzana Food International (FEI: 3008341023) has 28 FDA import refusal record(s) in our database, spanning from 10/5/2010 to 5/18/2016.
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. Lorenzana Food International's FEI number is 3008341023.
What types of violations has Lorenzana Food International received?
Lorenzana Food International 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 Lorenzana Food International come from?
All FDA import refusal data for Lorenzana Food International 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.