Bestgreen Industrial Co Ltd

⚠️ High Risk

FEI: 3011695926 • Xi Li • CHINA

FEI

FEI Number

3011695926

📍

Location

Xi Li

🇨🇳

Country

CHINA

🏢

Address

No 12 Industry 2nd Rd, , Xi Li, , China

High Risk

FDA Import Risk Assessment

51.9

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

8/16/2016

Latest Refusal

9/23/2015

Earliest Refusal

Score Breakdown

Violation Severity

60.4×40%

Refusal Volume

58.9×30%

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

1631×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

11823×

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).

328022×

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.

50818×

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
8/16/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
8/15/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	New Orleans District Office (NOL-DO)
8/12/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	New Orleans District Office (NOL-DO)
8/4/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/3/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
8/3/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/3/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 508NO 510(K)	New Orleans District Office (NOL-DO)
8/3/2016	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
8/3/2016	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/2/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
8/2/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/26/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 3280FRNMFGREG	Division of Southeast Imports (DSEI)
7/26/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New York District Office (NYK-DO)
7/11/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/11/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
6/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
6/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
5/24/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/23/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	New Orleans District Office (NOL-DO)
5/23/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
5/20/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
5/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	Division of Southeast Imports (DSEI)
5/5/2016	78PIAVIBRATOR FOR CLIMAX CONTROL OF PREMATURE EJACULATION	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
4/18/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
4/18/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
4/15/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/18/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
3/11/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/19/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED	New Orleans District Office (NOL-DO)
2/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/27/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 508NO 510(K)	Division of Southeast Imports (DSEI)
11/30/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
11/10/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
10/22/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS	Division of Southeast Imports (DSEI)
9/29/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED	New Orleans District Office (NOL-DO)
9/25/2015	89IROVIBRATOR, THERAPEUTIC	16DIRECTIONS	New Orleans District Office (NOL-DO)
9/23/2015	89IROVIBRATOR, THERAPEUTIC	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Bestgreen Industrial Co Ltd's FDA import refusal history?

Bestgreen Industrial Co Ltd (FEI: 3011695926) has 38 FDA import refusal record(s) in our database, spanning from 9/23/2015 to 8/16/2016.

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. Bestgreen Industrial Co Ltd's FEI number is 3011695926.

What types of violations has Bestgreen Industrial Co Ltd received?

Bestgreen Industrial Co Ltd 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 Bestgreen Industrial Co Ltd come from?

All FDA import refusal data for Bestgreen Industrial Co Ltd 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.