ROY

⚠️ High Risk

FEI: 3017459706 • Guangzhou • CHINA

FEI

FEI Number

3017459706

📍

Location

Guangzhou

🇨🇳

Country

CHINA

🏢

Address

Baiyunroom 203 Buildingno 16, Co Cultural Creativity Industry, Guangzhou, , China

High Risk

FDA Import Risk Assessment

51.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/6/2022

Latest Refusal

11/6/2020

Earliest Refusal

Score Breakdown

Violation Severity

54.9×40%

Refusal Volume

52.4×30%

Recency

19.7×20%

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

11825×

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).

328024×

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.

24804×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

Date	Product	Violations	Division
1/6/2022	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
2/8/2021	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/8/2021	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/8/2021	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/8/2021	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/8/2021	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
1/20/2021	86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/20/2021	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/20/2021	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/30/2020	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/30/2020	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/23/2020	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/23/2020	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/23/2020	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2020	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/18/2020	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/18/2020	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/18/2020	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/18/2020	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/18/2020	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/18/2020	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/18/2020	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/17/2020	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of West Coast Imports (DWCI)
11/12/2020	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of West Coast Imports (DWCI)
11/6/2020	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 2480RXPERSONAL 508NO 510(K)	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ROY's FDA import refusal history?

ROY (FEI: 3017459706) has 25 FDA import refusal record(s) in our database, spanning from 11/6/2020 to 1/6/2022.

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. ROY's FEI number is 3017459706.

What types of violations has ROY received?

ROY 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 ROY come from?

All FDA import refusal data for ROY 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.