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Nantong Chengxin Optical Instrument Co., Ltd.

⚠️ Moderate Risk

FEI: 3009662227 • Nantong, Jiangsu • CHINA

FEI

FEI Number

3009662227

📍

Location

Nantong, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

ONE GROUP, LIGANG VILLAGE, WUJIE TOWN, TONGZHOU DISTRICT, Nantong, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

28.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
4/1/2013
Latest Refusal
8/6/2012
Earliest Refusal

Score Breakdown

Violation Severity
46.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2783×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

472×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
4/1/2013
95REVLASER AIMING PRODUCT, NON-VISBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
278NO TAG
Seattle District Office (SEA-DO)
8/6/2012
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
278NO TAG
47NON STD
Baltimore District Office (BLT-DO)
8/6/2012
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
278NO TAG
47NON STD
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Nantong Chengxin Optical Instrument Co., Ltd.'s FDA import refusal history?

Nantong Chengxin Optical Instrument Co., Ltd. (FEI: 3009662227) has 3 FDA import refusal record(s) in our database, spanning from 8/6/2012 to 4/1/2013.

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. Nantong Chengxin Optical Instrument Co., Ltd.'s FEI number is 3009662227.

What types of violations has Nantong Chengxin Optical Instrument Co., Ltd. received?

Nantong Chengxin Optical Instrument Co., Ltd. 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 Nantong Chengxin Optical Instrument Co., Ltd. come from?

All FDA import refusal data for Nantong Chengxin Optical Instrument Co., Ltd. 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.