G-Spot International Co., Ltd

⚠️ Moderate Risk

FEI: 3007156919 • Sanchong Citysanchong City • TAIWAN

FEI

FEI Number

3007156919

📍

Location

Sanchong Citysanchong City

🇹🇼

Country

TAIWAN

🏢

Address

2nd Fl, No 3, Sec 4, Chongsin Rd, , Sanchong Citysanchong City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

34.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/21/2008

Latest Refusal

11/3/2008

Earliest Refusal

Score Breakdown

Violation Severity

43.3×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

70.0×10%

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

Violation Summary

1187×

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).

2237×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

3337×

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.

Refusal History

Date	Product	Violations	Division
11/21/2008	78FHACLAMP, PENILE	118NOT LISTED 223FALSE 333LACKS FIRM	New York District Office (NYK-DO)
11/12/2008	78FHACLAMP, PENILE	118NOT LISTED 223FALSE 333LACKS FIRM	New York District Office (NYK-DO)
11/3/2008	78FHACLAMP, PENILE	118NOT LISTED 223FALSE 333LACKS FIRM	New York District Office (NYK-DO)
11/3/2008	78FHACLAMP, PENILE	118NOT LISTED 223FALSE 333LACKS FIRM	New York District Office (NYK-DO)
11/3/2008	78FHACLAMP, PENILE	118NOT LISTED 223FALSE 333LACKS FIRM	New York District Office (NYK-DO)
11/3/2008	78FHACLAMP, PENILE	118NOT LISTED 223FALSE 333LACKS FIRM	New York District Office (NYK-DO)
11/3/2008	78FHACLAMP, PENILE	118NOT LISTED 223FALSE 333LACKS FIRM	New York District Office (NYK-DO)

Frequently Asked Questions

What is G-Spot International Co., Ltd's FDA import refusal history?

G-Spot International Co., Ltd (FEI: 3007156919) has 7 FDA import refusal record(s) in our database, spanning from 11/3/2008 to 11/21/2008.

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. G-Spot International Co., Ltd's FEI number is 3007156919.

What types of violations has G-Spot International Co., Ltd received?

G-Spot International Co., Ltd has been cited for 3 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 G-Spot International Co., Ltd come from?

All FDA import refusal data for G-Spot International 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.