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Zesto Philippines

⚠️ Moderate Risk

FEI: 3000318353 • Quezon City • PHILIPPINES

FEI

FEI Number

3000318353

📍

Location

Quezon City

🇵🇭
🏢

Address

74 Dela Cruz Sitio Gitna, , Quezon City, , Philippines

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
3/22/2016
Latest Refusal
3/22/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4821×

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.

831×

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.

Refusal History

DateProductViolationsDivision
3/22/2016
22KEI04SOURSOP, JUICE, OTHER FRUIT JUICES OR CONCENTRATES
482NUTRIT LBL
83NO PROCESS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Zesto Philippines's FDA import refusal history?

Zesto Philippines (FEI: 3000318353) has 1 FDA import refusal record(s) in our database, spanning from 3/22/2016 to 3/22/2016.

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. Zesto Philippines's FEI number is 3000318353.

What types of violations has Zesto Philippines received?

Zesto Philippines has been cited for 2 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 Philippines come from?

All FDA import refusal data for Zesto Philippines 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.