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Celergen

⚠️ Moderate Risk

FEI: 3008630355 • Singapore • SINGAPORE

FEI

FEI Number

3008630355

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

401 Commonwealth Drive, , Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/16/2010
Latest Refusal
12/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4882×

HEALTH C

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 bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
12/16/2010
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
488HEALTH C
Cincinnati District Office (CIN-DO)
12/16/2010
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
488HEALTH C
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Celergen's FDA import refusal history?

Celergen (FEI: 3008630355) has 2 FDA import refusal record(s) in our database, spanning from 12/16/2010 to 12/16/2010.

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. Celergen's FEI number is 3008630355.

What types of violations has Celergen received?

Celergen has been cited for 1 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 Celergen come from?

All FDA import refusal data for Celergen 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.