Changtai Sports & Bags Products Factory

⚠️ Moderate Risk

FEI: 3004521983 • Guang, Dong Province • CHINA

FEI

FEI Number

3004521983

📍

Location

Guang, Dong Province

🇨🇳

Country

CHINA

🏢

Address

Lingxiz,Lia Bu, Dong Guan City, Guang, Dong Province, China

Moderate Risk

FDA Import Risk Assessment

40.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/20/2007

Latest Refusal

2/20/2007

Earliest Refusal

Score Breakdown

Violation Severity

35.6×40%

Refusal Volume

52.4×30%

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

Violation Summary

34125×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

1185×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

5082×

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

Date	Product	Violations	Division
2/20/2007	89MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/20/2007	89MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	118NOT LISTED 341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	118NOT LISTED 341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	118NOT LISTED 341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	118NOT LISTED 341REGISTERED	Los Angeles District Office (LOS-DO)
2/20/2007	89IQIORTHOSIS, LIMB BRACE	118NOT LISTED 341REGISTERED	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Changtai Sports & Bags Products Factory's FDA import refusal history?

Changtai Sports & Bags Products Factory (FEI: 3004521983) has 25 FDA import refusal record(s) in our database, spanning from 2/20/2007 to 2/20/2007.

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. Changtai Sports & Bags Products Factory's FEI number is 3004521983.

What types of violations has Changtai Sports & Bags Products Factory received?

Changtai Sports & Bags Products Factory has been cited for 3 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 Changtai Sports & Bags Products Factory come from?

All FDA import refusal data for Changtai Sports & Bags Products Factory 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.