Fcg Trading Philippines Inc
⚠️ Moderate Risk
FEI: 1000166466 • Quezon City, National Capital Region • PHILIPPINES
FEI Number
1000166466
Location
Quezon City, National Capital Region
Country
PHILIPPINESAddress
9 Dona Justina, , Quezon 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).
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
E COLI 157
The article appears to contain E. coli O157:H7 (EHEC), a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2010 | 16AGT01ANCHOVY | New York District Office (NYK-DO) | |
| 1/13/2010 | 21TGT14TAMARIND, DRIED OR PASTE | 249FILTHY | New York District Office (NYK-DO) |
| 12/18/2008 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | San Francisco District Office (SAN-DO) | |
| 12/18/2008 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | San Francisco District Office (SAN-DO) | |
| 5/5/2006 | 60LAL99ANALGESIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/26/2004 | 16AGT21HERRING | 308MFR INSAN | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Fcg Trading Philippines Inc's FDA import refusal history?
Fcg Trading Philippines Inc (FEI: 1000166466) has 6 FDA import refusal record(s) in our database, spanning from 7/26/2004 to 3/12/2010.
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. Fcg Trading Philippines Inc's FEI number is 1000166466.
What types of violations has Fcg Trading Philippines Inc received?
Fcg Trading Philippines Inc has been cited for 7 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 Fcg Trading Philippines Inc come from?
All FDA import refusal data for Fcg Trading Philippines 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.