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SKY PFM TECHNOLOGY

⚠️ Moderate Risk

FEI: 3016752907 • Zhangzhou, Fujian • CHINA

FEI

FEI Number

3016752907

📍

Location

Zhangzhou, Fujian

🇨🇳

Country

CHINA
🏢

Address

No. 89 Zhaoshang Avenue, Zhaoshangjuzhangzhou Kaifa Gangweizhen Longhai, Zhangzhou, Fujian, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/22/2020
Latest Refusal
10/22/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

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
10/22/2020
83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
2480RXPERSONAL
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SKY PFM TECHNOLOGY's FDA import refusal history?

SKY PFM TECHNOLOGY (FEI: 3016752907) has 1 FDA import refusal record(s) in our database, spanning from 10/22/2020 to 10/22/2020.

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. SKY PFM TECHNOLOGY's FEI number is 3016752907.

What types of violations has SKY PFM TECHNOLOGY received?

SKY PFM TECHNOLOGY 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 SKY PFM TECHNOLOGY come from?

All FDA import refusal data for SKY PFM TECHNOLOGY 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.