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Sara Michelle Exports

⚠️ Moderate Risk

FEI: 3006312993 • Imus, Calabarzon • PHILIPPINES

FEI

FEI Number

3006312993

📍

Location

Imus, Calabarzon

🇵🇭
🏢

Address

24 Delgado, St. Ph. 4-A Pinagbuklod Bps, Imus, Calabarzon, Philippines

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/14/2009
Latest Refusal
2/14/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

112×

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).

33202×

TRANSFAT

The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].

Refusal History

DateProductViolationsDivision
2/14/2009
33LGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
3320TRANSFAT
Baltimore District Office (BLT-DO)
2/14/2009
33LGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
3320TRANSFAT
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Sara Michelle Exports's FDA import refusal history?

Sara Michelle Exports (FEI: 3006312993) has 2 FDA import refusal record(s) in our database, spanning from 2/14/2009 to 2/14/2009.

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. Sara Michelle Exports's FEI number is 3006312993.

What types of violations has Sara Michelle Exports received?

Sara Michelle Exports 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 Sara Michelle Exports come from?

All FDA import refusal data for Sara Michelle Exports 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.