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Energy Tech Development Company

⚠️ Moderate Risk

FEI: 3006623829 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3006623829

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Bldg C F 14, 555 Fahuazhenlu, Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

49.3
LowModerateHighCritical

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

Statistics

28
Total Refusals
4
Unique Violations
5/13/2008
Latest Refusal
2/25/2008
Earliest Refusal

Score Breakdown

Violation Severity
57.5×40%
Refusal Volume
54.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47626×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

1182×

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).

2352×

NOT IMPACT

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

3412×

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
5/13/2008
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/13/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
5/6/2008
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
Cincinnati District Office (CIN-DO)
4/28/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
4/28/2008
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Cincinnati District Office (CIN-DO)
4/28/2008
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
341REGISTERED
Cincinnati District Office (CIN-DO)
4/28/2008
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
341REGISTERED
Cincinnati District Office (CIN-DO)
2/25/2008
95RHEAUTO FOCUS CAMERA, GENERAL OPTICAL PRODUCTS, NON-MEDICAL
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Energy Tech Development Company's FDA import refusal history?

Energy Tech Development Company (FEI: 3006623829) has 28 FDA import refusal record(s) in our database, spanning from 2/25/2008 to 5/13/2008.

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. Energy Tech Development Company's FEI number is 3006623829.

What types of violations has Energy Tech Development Company received?

Energy Tech Development Company 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 Energy Tech Development Company come from?

All FDA import refusal data for Energy Tech Development Company 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.