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Ningbo Osaki Biotech Co., Ltd.

⚠️ High Risk

FEI: 3013373047 • Ningbo, Zhejiang • CHINA

FEI

FEI Number

3013373047

📍

Location

Ningbo, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

No. 521 Yuanbaoshan Road, Beilun, Ningbo, Zhejiang, China

High Risk

FDA Import Risk Assessment

59.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

14
Total Refusals
1
Unique Violations
12/14/2010
Latest Refusal
12/13/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
43.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

19714×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
12/14/2010
53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/14/2010
53MI01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/14/2010
53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/14/2010
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/14/2010
53GI05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/14/2010
53GC01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/14/2010
53CC03EYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/13/2010
53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/13/2010
53MI01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/13/2010
53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/13/2010
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/13/2010
53GI05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/13/2010
53GC01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Los Angeles District Office (LOS-DO)
12/13/2010
53CC03EYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Ningbo Osaki Biotech Co., Ltd.'s FDA import refusal history?

Ningbo Osaki Biotech Co., Ltd. (FEI: 3013373047) has 14 FDA import refusal record(s) in our database, spanning from 12/13/2010 to 12/14/2010.

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. Ningbo Osaki Biotech Co., Ltd.'s FEI number is 3013373047.

What types of violations has Ningbo Osaki Biotech Co., Ltd. received?

Ningbo Osaki Biotech Co., Ltd. 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 Ningbo Osaki Biotech Co., Ltd. come from?

All FDA import refusal data for Ningbo Osaki Biotech 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.