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CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD.

⚠️ Moderate Risk

FEI: 3007686508 • Chengdu, Sichuan • CHINA

FEI

FEI Number

3007686508

📍

Location

Chengdu, Sichuan

🇨🇳

Country

CHINA
🏢

Address

ROOM 8-134 HOLLYWOOD COMMERICLE PLAZA, NO. 18 , SOUTH 3RD BLOCK SECOND CIRCLE, Chengdu, Sichuan, China

Moderate Risk

FDA Import Risk Assessment

36.7
LowModerateHighCritical

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

Statistics

8
Total Refusals
6
Unique Violations
5/24/2011
Latest Refusal
1/12/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.5×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
58.8×10%
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

3335×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3365×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

3445×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

2782×

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.

4761×

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).

Refusal History

DateProductViolationsDivision
5/24/2011
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
333LACKS FIRM
336INCONSPICU
344WARNINGS
Los Angeles District Office (LOS-DO)
5/24/2011
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
333LACKS FIRM
336INCONSPICU
344WARNINGS
Los Angeles District Office (LOS-DO)
5/24/2011
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
333LACKS FIRM
336INCONSPICU
344WARNINGS
Los Angeles District Office (LOS-DO)
5/24/2011
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
333LACKS FIRM
336INCONSPICU
344WARNINGS
Los Angeles District Office (LOS-DO)
5/24/2011
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
333LACKS FIRM
336INCONSPICU
344WARNINGS
Los Angeles District Office (LOS-DO)
6/3/2010
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
476NO REGISTR
Los Angeles District Office (LOS-DO)
1/12/2010
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
278NO TAG
47NON STD
Los Angeles District Office (LOS-DO)
1/12/2010
95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
278NO TAG
47NON STD
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD.'s FDA import refusal history?

CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD. (FEI: 3007686508) has 8 FDA import refusal record(s) in our database, spanning from 1/12/2010 to 5/24/2011.

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. CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD.'s FEI number is 3007686508.

What types of violations has CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD. received?

CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD. has been cited for 6 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 CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD. come from?

All FDA import refusal data for CHENGDU FOUNTAIN OPTICAL & ELECTRONIC 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.