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Guzent Inc.

⚠️ Moderate Risk

FEI: 3006647335 • Q.C. • PHILIPPINES

FEI

FEI Number

3006647335

📍

Location

Q.C.

🇵🇭
🏢

Address

Sitio Gitna 80, Kaybiga, , Novaliches, Q.C., , Philippines

Moderate Risk

FDA Import Risk Assessment

39.4
LowModerateHighCritical

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

Statistics

5
Total Refusals
4
Unique Violations
12/15/2011
Latest Refusal
4/25/2008
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
13.7×10%
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

114×

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).

643×

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.

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

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
12/15/2011
21SEE24PALM NUT (PALM FRUIT, SUGAR PALM) (SUBTROPICAL AND TROPICAL FRUIT)
11UNSAFE COL
274COLOR LBLG
Chicago District Office (CHI-DO)
8/6/2010
24TEE39HEART OF PALM (LEAF & STEM VEGETABLE)
11UNSAFE COL
64YELLOW #5
Chicago District Office (CHI-DO)
8/6/2010
24TEE39HEART OF PALM (LEAF & STEM VEGETABLE)
11UNSAFE COL
64YELLOW #5
Chicago District Office (CHI-DO)
8/6/2010
24TEE39HEART OF PALM (LEAF & STEM VEGETABLE)
11UNSAFE COL
64YELLOW #5
Chicago District Office (CHI-DO)
4/25/2008
24AGE06GARBANZO BEAN
83NO PROCESS
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Guzent Inc.'s FDA import refusal history?

Guzent Inc. (FEI: 3006647335) has 5 FDA import refusal record(s) in our database, spanning from 4/25/2008 to 12/15/2011.

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. Guzent Inc.'s FEI number is 3006647335.

What types of violations has Guzent Inc. received?

Guzent 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 Guzent Inc. come from?

All FDA import refusal data for Guzent 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.