Longyan Foreign Trade General Corp.

⚠️ Moderate Risk

FEI: 3002820044 • Fujian • CHINA

FEI

FEI Number

3002820044

📍

Location

Fujian

🇨🇳

Country

CHINA

🏢

Address

5th Floo, Lijie Building A, Huasheng, , Fujian, , China

Moderate Risk

FDA Import Risk Assessment

37.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/17/2005

Latest Refusal

10/3/2001

Earliest Refusal

Score Breakdown

Violation Severity

51.0×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

Frequency

41.4×10%

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

Violation Summary

34110×

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).

50810×

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.

1189×

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).

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

Date	Product	Violations	Division
2/17/2005	80FLKTHERMOMETER, CLINICAL MERCURY	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/3/2004	80FLKTHERMOMETER, CLINICAL MERCURY	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/14/2003	80FPASET, ADMINISTRATION, INTRAVASCULAR	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
10/9/2003	80FLKTHERMOMETER, CLINICAL MERCURY	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
8/15/2003	80KZHINTRODUCER, SYRINGE NEEDLE	118NOT LISTED	Florida District Office (FLA-DO)
7/25/2003	80FLKTHERMOMETER, CLINICAL MERCURY	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/18/2003	80FMFSYRINGE, PISTON	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
2/10/2003	80FLKTHERMOMETER, CLINICAL MERCURY	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
9/19/2002	78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/17/2002	80FLKTHERMOMETER, CLINICAL MERCURY	237NO PMA	Florida District Office (FLA-DO)
4/8/2002	79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/22/2002	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2001	80FLKTHERMOMETER, CLINICAL MERCURY	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/3/2001	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Longyan Foreign Trade General Corp.'s FDA import refusal history?

Longyan Foreign Trade General Corp. (FEI: 3002820044) has 14 FDA import refusal record(s) in our database, spanning from 10/3/2001 to 2/17/2005.

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. Longyan Foreign Trade General Corp.'s FEI number is 3002820044.

What types of violations has Longyan Foreign Trade General Corp. received?

Longyan Foreign Trade General Corp. has been cited for 4 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 Longyan Foreign Trade General Corp. come from?

All FDA import refusal data for Longyan Foreign Trade General Corp. 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.