Safeskin Medical & Scientific (Thailand) Ltd.

⚠️ High Risk

FEI: 1000297006 • Sadao, Songkhla • THAILAND

FEI

FEI Number

1000297006

📍

Location

Sadao, Songkhla

🇹🇭

Country

THAILAND

🏢

Address

200-Moo-8 Kanchanavanich Road, Tambol Prik, Sadao, Songkhla, Thailand

High Risk

FDA Import Risk Assessment

50.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

10/2/2018

Latest Refusal

5/6/2002

Earliest Refusal

Score Breakdown

Violation Severity

69.0×40%

Refusal Volume

64.8×30%

Recency

0.0×20%

Frequency

33.5×10%

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

47755×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

27804×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

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).

3411×

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

Date	Product	Violations	Division
10/2/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
10/2/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/27/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	2780DEVICEGMPS 477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	2780DEVICEGMPS 477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	2780DEVICEGMPS 477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	2780DEVICEGMPS 477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/11/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
9/10/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
9/10/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
9/10/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
9/10/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
9/10/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
9/10/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
9/10/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
9/5/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northeast Imports (DNEI)
9/5/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northeast Imports (DNEI)
9/5/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Northeast Imports (DNEI)
9/4/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southwest Imports (DSWI)
8/31/2018	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southwest Imports (DSWI)
8/6/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	477HOLES	Division of Southeast Imports (DSEI)
8/6/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	341REGISTERED 477HOLES	Division of Southeast Imports (DSEI)
8/6/2018	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	118NOT LISTED 477HOLES	Division of Southeast Imports (DSEI)
5/6/2002	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	New England District Office (NWE-DO)

Frequently Asked Questions

What is Safeskin Medical & Scientific (Thailand) Ltd.'s FDA import refusal history?

Safeskin Medical & Scientific (Thailand) Ltd. (FEI: 1000297006) has 55 FDA import refusal record(s) in our database, spanning from 5/6/2002 to 10/2/2018.

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. Safeskin Medical & Scientific (Thailand) Ltd.'s FEI number is 1000297006.

What types of violations has Safeskin Medical & Scientific (Thailand) Ltd. received?

Safeskin Medical & Scientific (Thailand) Ltd. 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 Safeskin Medical & Scientific (Thailand) Ltd. come from?

All FDA import refusal data for Safeskin Medical & Scientific (Thailand) 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.