AIWEI INTERNATIONAL CO LIMITED

⚠️ Moderate Risk

FEI: 3017397248 • Shenzhen • CHINA

FEI

FEI Number

3017397248

📍

Location

Shenzhen

🇨🇳

Country

CHINA

🏢

Address

3, 4 Xinhe Road F No.40shangmugu Industrial; Longgang District, Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

43.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/10/2020

Latest Refusal

12/4/2020

Earliest Refusal

Score Breakdown

Violation Severity

53.0×40%

Refusal Volume

41.3×30%

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

11812×

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).

328012×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

50812×

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.

2378×

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).

3337×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3415×

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).

Refusal History

Date	Product	Violations	Division
12/10/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 333LACKS FIRM 508NO 510(K)	Division of West Coast Imports (DWCI)
12/10/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 333LACKS FIRM 508NO 510(K)	Division of West Coast Imports (DWCI)
12/10/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 333LACKS FIRM 508NO 510(K)	Division of West Coast Imports (DWCI)
12/9/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
12/9/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
12/9/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
12/8/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
12/8/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
12/4/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 3280FRNMFGREG 333LACKS FIRM 508NO 510(K)	Division of West Coast Imports (DWCI)
12/4/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 3280FRNMFGREG 333LACKS FIRM 508NO 510(K)	Division of West Coast Imports (DWCI)
12/4/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 333LACKS FIRM 508NO 510(K)	Division of West Coast Imports (DWCI)
12/4/2020	80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE	118NOT LISTED 237NO PMA 3280FRNMFGREG 333LACKS FIRM 508NO 510(K)	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is AIWEI INTERNATIONAL CO LIMITED's FDA import refusal history?

AIWEI INTERNATIONAL CO LIMITED (FEI: 3017397248) has 12 FDA import refusal record(s) in our database, spanning from 12/4/2020 to 12/10/2020.

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. AIWEI INTERNATIONAL CO LIMITED's FEI number is 3017397248.

What types of violations has AIWEI INTERNATIONAL CO LIMITED received?

AIWEI INTERNATIONAL CO LIMITED has been cited for 6 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 AIWEI INTERNATIONAL CO LIMITED come from?

All FDA import refusal data for AIWEI INTERNATIONAL CO LIMITED 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.