Sperian Eye & Face Protection Inc
⚠️ High Risk
FEI: 1418051 • Platteville, WI • UNITED STATES
FEI Number
1418051
Location
Platteville, WI
Country
UNITED STATESAddress
825 E Business Highway 151, , Platteville, WI, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
FILTH
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Division of Southwest Imports (DSWI) |
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Division of Southwest Imports (DSWI) |
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Southwest Import District Office (SWI-DO) |
| 2/2/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 78STERILITY | Division of Southwest Imports (DSWI) |
| 2/2/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 78STERILITY | Division of Southwest Imports (DSWI) |
| 2/2/2017 | 65FAK06WATER, PURIFIED (EYEWASH) | 78STERILITY | Division of Southwest Imports (DSWI) |
| 10/6/2016 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Division of Southwest Imports (DSWI) |
| 7/27/2016 | 65FAK06WATER, PURIFIED (EYEWASH) | 3761FILTH | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Sperian Eye & Face Protection Inc's FDA import refusal history?
Sperian Eye & Face Protection Inc (FEI: 1418051) has 13 FDA import refusal record(s) in our database, spanning from 7/27/2016 to 2/3/2017.
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. Sperian Eye & Face Protection Inc's FEI number is 1418051.
What types of violations has Sperian Eye & Face Protection Inc received?
Sperian Eye & Face Protection Inc 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 Sperian Eye & Face Protection Inc come from?
All FDA import refusal data for Sperian Eye & Face Protection 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.