OSI Optoelectronics Inc.

⚠️ Moderate Risk

FEI: 3006713849 • Hawthorne, CA • UNITED STATES

FEI

FEI Number

3006713849

📍

Location

Hawthorne, CA

🇺🇸

Country

UNITED STATES

🏢

Address

12525 Chadron Ave, , Hawthorne, CA, United States

Moderate Risk

FDA Import Risk Assessment

47.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/26/2014

Latest Refusal

9/26/2014

Earliest Refusal

Score Breakdown

Violation Severity

56.7×40%

Refusal Volume

50.4×30%

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

11822×

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.

50822×

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
9/26/2014	73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	73CBRANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74MHXMONITOR, PHYSIOLOGICAL, PATIENT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
9/26/2014	74DSIDETECTOR AND ALARM, ARRHYTHMIA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is OSI Optoelectronics Inc.'s FDA import refusal history?

OSI Optoelectronics Inc. (FEI: 3006713849) has 22 FDA import refusal record(s) in our database, spanning from 9/26/2014 to 9/26/2014.

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. OSI Optoelectronics Inc.'s FEI number is 3006713849.

What types of violations has OSI Optoelectronics Inc. received?

OSI Optoelectronics Inc. 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 OSI Optoelectronics Inc. come from?

All FDA import refusal data for OSI Optoelectronics Inc. 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.