Optical Instrument Mfg.Ind.Co.Ltd
⚠️ Moderate Risk
FEI: 3001835101 • Taipei • TAIWAN
FEI Number
3001835101
Location
Taipei
Country
TAIWANAddress
No. 1, Lane 252, Chung Cheng Road, , Shun Lin, Taipei, , Taiwan
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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 6/10/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Chicago District Office (CHI-DO) |
| 6/10/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Chicago District Office (CHI-DO) | |
| 2/3/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Los Angeles District Office (LOS-DO) | |
| 6/14/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
| 5/10/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Optical Instrument Mfg.Ind.Co.Ltd's FDA import refusal history?
Optical Instrument Mfg.Ind.Co.Ltd (FEI: 3001835101) has 6 FDA import refusal record(s) in our database, spanning from 5/10/2002 to 2/28/2005.
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. Optical Instrument Mfg.Ind.Co.Ltd's FEI number is 3001835101.
What types of violations has Optical Instrument Mfg.Ind.Co.Ltd received?
Optical Instrument Mfg.Ind.Co.Ltd 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 Optical Instrument Mfg.Ind.Co.Ltd come from?
All FDA import refusal data for Optical Instrument Mfg.Ind.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.