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Dr. Ci Labo Co Ltd

⚠️ Moderate Risk

FEI: 3004509870 • Shibuya, Tokyo • JAPAN

FEI

FEI Number

3004509870

📍

Location

Shibuya, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 1-39, Hiroo, Shibuya, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

46.3
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
9/15/2011
Latest Refusal
4/15/2008
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
23.4×10%
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

758×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
9/15/2011
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/15/2011
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/15/2011
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/15/2011
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/20/2011
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/15/2008
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/15/2008
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/15/2008
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dr. Ci Labo Co Ltd's FDA import refusal history?

Dr. Ci Labo Co Ltd (FEI: 3004509870) has 8 FDA import refusal record(s) in our database, spanning from 4/15/2008 to 9/15/2011.

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. Dr. Ci Labo Co Ltd's FEI number is 3004509870.

What types of violations has Dr. Ci Labo Co Ltd received?

Dr. Ci Labo Co Ltd 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 Dr. Ci Labo Co Ltd come from?

All FDA import refusal data for Dr. Ci Labo Co Ltd 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.