South East Asian Optical Pte

⚠️ Moderate Risk

FEI: 3005861690 • Katong • SINGAPORE

FEI

FEI Number

3005861690

📍

Location

Katong

🇸🇬

Country

SINGAPORE

🏢

Address

6 Temasek Blvd 0905 Suntec, , Katong, , Singapore

Moderate Risk

FDA Import Risk Assessment

38.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/22/2007

Latest Refusal

2/22/2007

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

80.0×10%

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

3418×

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).

5088×

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
2/22/2007	86LRXCASE, CONTACT LENS	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	86HPCSET, LENS, TRIAL, OPHTHALMIC	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	86HLIOPHTHALMOSCOPE, AC-POWERED	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	86HOSPROJECTOR, OPHTHALMIC	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	86HLHPUPILLOMETER, MANUAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	86NQEMICROSCOPE, SPECULAR	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is South East Asian Optical Pte's FDA import refusal history?

South East Asian Optical Pte (FEI: 3005861690) has 8 FDA import refusal record(s) in our database, spanning from 2/22/2007 to 2/22/2007.

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. South East Asian Optical Pte's FEI number is 3005861690.

What types of violations has South East Asian Optical Pte received?

South East Asian Optical Pte has been cited for 2 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 South East Asian Optical Pte come from?

All FDA import refusal data for South East Asian Optical Pte 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.