Zesto Corporation
⚠️ Moderate Risk
FEI: 3003330112 • Metro Manila, National Capital Region • PHILIPPINES
FEI Number
3003330112
Location
Metro Manila, National Capital Region
Country
PHILIPPINESAddress
74 P. dela Cruz Street, , Metro Manila, 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).
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
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).
JUICE %
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 the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2023 | 29BGT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 3/21/2023 | 29BGT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | Division of Southeast Imports (DSEI) | |
| 3/2/2009 | 30BGT06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | Los Angeles District Office (LOS-DO) | |
| 8/13/2007 | 29BEY20SOFT DRINK, ROOT FLAVORED (ROOT BEER, GINGER ALE, ETC.), CARBONATED | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 3/21/2005 | 29AEE07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 10/14/2004 | 29AGT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED | Los Angeles District Office (LOS-DO) | |
| 2/25/2003 | 04CGT07NOODLES, INSTANT | Los Angeles District Office (LOS-DO) | |
| 3/28/2002 | 21VEE05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Zesto Corporation's FDA import refusal history?
Zesto Corporation (FEI: 3003330112) has 8 FDA import refusal record(s) in our database, spanning from 3/28/2002 to 3/21/2023.
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. Zesto Corporation's FEI number is 3003330112.
What types of violations has Zesto Corporation received?
Zesto 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 Zesto Corporation come from?
All FDA import refusal data for Zesto 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.