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Pt. Supravisi Rama Optik Mfgjl. Resinda Raya

⚠️ Moderate Risk

FEI: 3004188578 • Jakarta • INDONESIA

FEI

FEI Number

3004188578

📍

Location

Jakarta

🇮🇩

Country

INDONESIA
🏢

Address

Zona Industrial , Karawang 41361, Jawa, , Jakarta, , Indonesia

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
2/28/2005
Latest Refusal
2/28/2005
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3411×

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

DateProductViolationsDivision
2/28/2005
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
341REGISTERED
Los Angeles District Office (LOS-DO)
2/28/2005
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Pt. Supravisi Rama Optik Mfgjl. Resinda Raya's FDA import refusal history?

Pt. Supravisi Rama Optik Mfgjl. Resinda Raya (FEI: 3004188578) has 2 FDA import refusal record(s) in our database, spanning from 2/28/2005 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. Pt. Supravisi Rama Optik Mfgjl. Resinda Raya's FEI number is 3004188578.

What types of violations has Pt. Supravisi Rama Optik Mfgjl. Resinda Raya received?

Pt. Supravisi Rama Optik Mfgjl. Resinda Raya 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 Pt. Supravisi Rama Optik Mfgjl. Resinda Raya come from?

All FDA import refusal data for Pt. Supravisi Rama Optik Mfgjl. Resinda Raya 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.