Pacific Optics Electronics Co Ltd
⚠️ Moderate Risk
FEI: 3004604182 • Guangzhou, Guangdong • CHINA
FEI Number
3004604182
Location
Guangzhou, Guangdong
Country
CHINAAddress
Tower A1 Room 1101, No 5 Panjiangnei, Guangzhou, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2014 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 341REGISTERED | New York District Office (NYK-DO) |
| 8/10/2007 | 86HMECHAIR, OPHTHALMIC, AC-POWERED | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86MVNLENS, CONTACT (DISPOSABLE) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86HQHEYE, ARTIFICIAL, NON-CUSTOM | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86HOSPROJECTOR, OPHTHALMIC | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86HKYTONOMETER, MANUAL | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86MVNLENS, CONTACT (DISPOSABLE) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86HLJOPHTHALMOSCOPE, BATTERY-POWERED | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86MVNLENS, CONTACT (DISPOSABLE) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86MMFPHOTOREFRACTOR | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86HKOREFRACTOMETER, OPHTHALMIC | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 86HRKTABLE, INSTRUMENT, MANUAL, OPHTHALMIC | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Pacific Optics Electronics Co Ltd's FDA import refusal history?
Pacific Optics Electronics Co Ltd (FEI: 3004604182) has 13 FDA import refusal record(s) in our database, spanning from 8/10/2007 to 4/2/2014.
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. Pacific Optics Electronics Co Ltd's FEI number is 3004604182.
What types of violations has Pacific Optics Electronics Co Ltd received?
Pacific Optics Electronics Co Ltd 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 Pacific Optics Electronics Co Ltd come from?
All FDA import refusal data for Pacific Optics Electronics 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.