Guangzhou Universal Optical Products Co., Ltd.

⚠️ Moderate Risk

FEI: 3004102006 • Huandu Area Guangzhou • CHINA

FEI

FEI Number

3004102006

📍

Location

Huandu Area Guangzhou

🇨🇳

Country

CHINA

🏢

Address

No. 2 Industry Area, Lion Hill Town, , Huandu Area Guangzhou, , China

Moderate Risk

FDA Import Risk Assessment

42.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/18/2012

Latest Refusal

6/10/2011

Earliest Refusal

Score Breakdown

Violation Severity

43.0×40%

Refusal Volume

49.7×30%

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

11820×

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).

34120×

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).

2357×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

Date	Product	Violations	Division
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQZFRAME, SPECTACLE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 235NOT IMPACT 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 235NOT IMPACT 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 235NOT IMPACT 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 235NOT IMPACT 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 235NOT IMPACT 341REGISTERED	New Orleans District Office (NOL-DO)
6/18/2012	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	118NOT LISTED 235NOT IMPACT 341REGISTERED	New Orleans District Office (NOL-DO)
6/10/2011	86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)	235NOT IMPACT	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Guangzhou Universal Optical Products Co., Ltd.'s FDA import refusal history?

Guangzhou Universal Optical Products Co., Ltd. (FEI: 3004102006) has 21 FDA import refusal record(s) in our database, spanning from 6/10/2011 to 6/18/2012.

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. Guangzhou Universal Optical Products Co., Ltd.'s FEI number is 3004102006.

What types of violations has Guangzhou Universal Optical Products Co., Ltd. received?

Guangzhou Universal Optical Products Co., Ltd. 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 Guangzhou Universal Optical Products Co., Ltd. come from?

All FDA import refusal data for Guangzhou Universal Optical Products 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.