D'World 2000 Enterprises Corporation
⚠️ Moderate Risk
FEI: 3004666662 • Quezon City, National Capital Region • PHILIPPINES
FEI Number
3004666662
Location
Quezon City, National Capital Region
Country
PHILIPPINESAddress
40 Examiner, , 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2008 | 45DG99COLOR ADJUNCTS (FOOD ADDITIVES FOR HUMAN USE) | San Francisco District Office (SAN-DO) | |
| 7/23/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 2/8/2008 | 50ACT01COLOR FOR FOODS, DRUGS AND COSMETICS (FD&C) (CERTIFIED) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 2/8/2008 | 50ACT01COLOR FOR FOODS, DRUGS AND COSMETICS (FD&C) (CERTIFIED) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 2/8/2008 | 50ACT01COLOR FOR FOODS, DRUGS AND COSMETICS (FD&C) (CERTIFIED) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 2/8/2008 | 50ACT01COLOR FOR FOODS, DRUGS AND COSMETICS (FD&C) (CERTIFIED) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 11/30/2007 | 38CGT99DRIED SOUP, N.E.C. | 249FILTHY | San Francisco District Office (SAN-DO) |
| 2/21/2006 | 09CGT13CREAM, SWEET, WHIPPING, TABLE, ETC. | San Francisco District Office (SAN-DO) | |
| 11/26/2001 | 21THT14TAMARIND, DRIED OR PASTE | 249FILTHY | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is D'World 2000 Enterprises Corporation's FDA import refusal history?
D'World 2000 Enterprises Corporation (FEI: 3004666662) has 9 FDA import refusal record(s) in our database, spanning from 11/26/2001 to 11/7/2008.
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. D'World 2000 Enterprises Corporation's FEI number is 3004666662.
What types of violations has D'World 2000 Enterprises Corporation received?
D'World 2000 Enterprises Corporation has been cited for 8 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 D'World 2000 Enterprises Corporation come from?
All FDA import refusal data for D'World 2000 Enterprises Corporation 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.