Spectra-Physics Lasers
⚠️ Moderate Risk
FEI: 2937312 • Mountain View, CA • UNITED STATES
FEI Number
2937312
Location
Mountain View, CA
Country
UNITED STATESAddress
1335 Terra Bella Ave, , Mountain View, CA, United States
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
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.
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.
Refusal History
Frequently Asked Questions
What is Spectra-Physics Lasers's FDA import refusal history?
Spectra-Physics Lasers (FEI: 2937312) has 2 FDA import refusal record(s) in our database, spanning from 2/18/2005 to 6/28/2005.
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. Spectra-Physics Lasers's FEI number is 2937312.
What types of violations has Spectra-Physics Lasers received?
Spectra-Physics Lasers 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 Spectra-Physics Lasers come from?
All FDA import refusal data for Spectra-Physics Lasers 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.