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Kindly Care Products Co., Ltd.

⚠️ Moderate Risk

FEI: 3014198397 • Foshan, Guangdong • CHINA

FEI

FEI Number

3014198397

📍

Location

Foshan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Danzao Village, 30 Guicheng Nanhai Dadaobei; Nanhai District, Foshan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/18/2020
Latest Refusal
6/12/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4793×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
9/18/2020
80NZJRESPIRATOR, N95, HOME USE
479DV QUALITY
508NO 510(K)
Division of Southeast Imports (DSEI)
7/22/2020
80FXXMASK, SURGICAL
479DV QUALITY
Division of Southeast Imports (DSEI)
6/12/2020
80MSHRESPIRATOR, SURGICAL
479DV QUALITY
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Kindly Care Products Co., Ltd.'s FDA import refusal history?

Kindly Care Products Co., Ltd. (FEI: 3014198397) has 3 FDA import refusal record(s) in our database, spanning from 6/12/2020 to 9/18/2020.

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. Kindly Care Products Co., Ltd.'s FEI number is 3014198397.

What types of violations has Kindly Care Products Co., Ltd. received?

Kindly Care Products 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 Kindly Care Products Co., Ltd. come from?

All FDA import refusal data for Kindly Care Products 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.