Gem Foods International, Inc.
⚠️ Moderate Risk
FEI: 3008742566 • Subic Bay Freeport Zone • PHILIPPINES
FEI Number
3008742566
Location
Subic Bay Freeport Zone
Country
PHILIPPINESAddress
Unit 26, Sampson Road, , Subic Bay Freeport Zone, , 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).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2014 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/20/2014 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/20/2014 | 63VDU99DEPIGMENTOR N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/14/2012 | 36AGT02BROWN SUGAR (SUCROSE FROM CANE) | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 9/10/2012 | 33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 9/10/2012 | 33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | 249FILTHY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Gem Foods International, Inc.'s FDA import refusal history?
Gem Foods International, Inc. (FEI: 3008742566) has 6 FDA import refusal record(s) in our database, spanning from 9/10/2012 to 5/20/2014.
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. Gem Foods International, Inc.'s FEI number is 3008742566.
What types of violations has Gem Foods International, Inc. received?
Gem Foods International, Inc. 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 Gem Foods International, Inc. come from?
All FDA import refusal data for Gem Foods International, 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.