PT Vision Ease
⚠️ Moderate Risk
FEI: 3003367816 • Bekasi, Jabotabek • INDONESIA
FEI Number
3003367816
Location
Bekasi, Jabotabek
Country
INDONESIAAddress
Jln Meranti 3 Blok L8 No. 8, , Bekasi, Jabotabek, Indonesia
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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).
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 |
|---|---|---|---|
| 1/13/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | San Francisco District Office (SAN-DO) | |
| 11/29/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/29/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/20/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 1/6/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 12/7/2001 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is PT Vision Ease's FDA import refusal history?
PT Vision Ease (FEI: 3003367816) has 6 FDA import refusal record(s) in our database, spanning from 12/7/2001 to 1/13/2005.
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. PT Vision Ease's FEI number is 3003367816.
What types of violations has PT Vision Ease received?
PT Vision Ease 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 PT Vision Ease come from?
All FDA import refusal data for PT Vision Ease 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.