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Pilot Optics International Corp., Ltd., Wenzhou

⚠️ Moderate Risk

FEI: 3008517911 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3008517911

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

25 Xing Guo Road, Longwan, Wenzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

24
Total Refusals
4
Unique Violations
11/14/2012
Latest Refusal
8/2/2005
Earliest Refusal

Score Breakdown

Violation Severity
56.1×40%
Refusal Volume
51.8×30%
Recency
0.0×20%
Frequency
32.9×10%
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

23515×

NOT IMPACT

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

2317×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

3413×

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).

1181×

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).

Refusal History

DateProductViolationsDivision
11/14/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New York District Office (NYK-DO)
2/28/2012
86HOISPECTACLE, MAGNIFYING
231LENS CERT
235NOT IMPACT
Chicago District Office (CHI-DO)
1/31/2012
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
New York District Office (NYK-DO)
1/31/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
New York District Office (NYK-DO)
1/5/2012
86HOISPECTACLE, MAGNIFYING
231LENS CERT
New York District Office (NYK-DO)
1/5/2012
86HOISPECTACLE, MAGNIFYING
231LENS CERT
New York District Office (NYK-DO)
1/5/2012
86HOISPECTACLE, MAGNIFYING
231LENS CERT
New York District Office (NYK-DO)
12/30/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
New York District Office (NYK-DO)
12/30/2011
86HOISPECTACLE, MAGNIFYING
231LENS CERT
New York District Office (NYK-DO)
12/30/2011
86HOISPECTACLE, MAGNIFYING
231LENS CERT
New York District Office (NYK-DO)
12/29/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/29/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/29/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/29/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/21/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New York District Office (NYK-DO)
12/21/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
New York District Office (NYK-DO)
12/9/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/9/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/9/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/9/2011
86HOISPECTACLE, MAGNIFYING
235NOT IMPACT
Detroit District Office (DET-DO)
12/9/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Detroit District Office (DET-DO)
6/30/2011
86HOISPECTACLE, MAGNIFYING
341REGISTERED
Detroit District Office (DET-DO)
6/30/2011
86HOISPECTACLE, MAGNIFYING
341REGISTERED
Detroit District Office (DET-DO)
8/2/2005
86HOISPECTACLE, MAGNIFYING
118NOT LISTED
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Pilot Optics International Corp., Ltd., Wenzhou's FDA import refusal history?

Pilot Optics International Corp., Ltd., Wenzhou (FEI: 3008517911) has 24 FDA import refusal record(s) in our database, spanning from 8/2/2005 to 11/14/2012.

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. Pilot Optics International Corp., Ltd., Wenzhou's FEI number is 3008517911.

What types of violations has Pilot Optics International Corp., Ltd., Wenzhou received?

Pilot Optics International Corp., Ltd., Wenzhou 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 Pilot Optics International Corp., Ltd., Wenzhou come from?

All FDA import refusal data for Pilot Optics International Corp., Ltd., Wenzhou 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.