HUNAN RUNMEI GENE TRCHNOLOGY COLTD

⚠️ Moderate Risk

FEI: 3016957496 • Hunan, Hunan • CHINA

FEI

FEI Number

3016957496

📍

Location

Hunan, Hunan

🇨🇳

Country

CHINA

🏢

Address

Bldg 3 Rm 401, 1048 Zhong Qing Road, Hunan, Hunan, China

Moderate Risk

FDA Import Risk Assessment

39.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/18/2022

Latest Refusal

10/28/2020

Earliest Refusal

Score Breakdown

Violation Severity

58.9×40%

Refusal Volume

31.3×30%

Recency

9.3×20%

Frequency

43.3×10%

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

5085×

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.

1183×

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).

3411×

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
3/18/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Northern Border Imports (DNBI)
2/5/2021	83OTTRESEARCH USE ONLY/MICROBIOLOGY	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
11/12/2020	83JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT	508NO 510(K)	Division of Northern Border Imports (DNBI)
11/12/2020	83JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/6/2020	83JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT	118NOT LISTED 508NO 510(K)	Division of Northern Border Imports (DNBI)
10/28/2020	88KDTCONTAINER, SPECIMEN MAILER AND STORAGE	508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HUNAN RUNMEI GENE TRCHNOLOGY COLTD's FDA import refusal history?

HUNAN RUNMEI GENE TRCHNOLOGY COLTD (FEI: 3016957496) has 6 FDA import refusal record(s) in our database, spanning from 10/28/2020 to 3/18/2022.

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. HUNAN RUNMEI GENE TRCHNOLOGY COLTD's FEI number is 3016957496.

What types of violations has HUNAN RUNMEI GENE TRCHNOLOGY COLTD received?

HUNAN RUNMEI GENE TRCHNOLOGY COLTD 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 HUNAN RUNMEI GENE TRCHNOLOGY COLTD come from?

All FDA import refusal data for HUNAN RUNMEI GENE TRCHNOLOGY COLTD 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.