Takka Inter Service Co., Ltd.

⚠️ Moderate Risk

FEI: 3008419342 • Mueang Samut Prakan, Samut Prakan • THAILAND

FEI

FEI Number

3008419342

📍

Location

Mueang Samut Prakan, Samut Prakan

🇹🇭

Country

THAILAND

🏢

Address

199, 149 Bang Duan Alley, Mueang Samut Prakan, Samut Prakan, Thailand

Moderate Risk

FDA Import Risk Assessment

42.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/23/2011

Latest Refusal

9/23/2011

Earliest Refusal

Score Breakdown

Violation Severity

45.8×40%

Refusal Volume

45.6×30%

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

Violation Summary

11810×

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).

4716×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4756×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

30005×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

163×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3353×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

Date	Product	Violations	Division
9/23/2011	53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
9/23/2011	53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
9/23/2011	53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
9/23/2011	53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
9/23/2011	53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
9/23/2011	53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 475COSMETLBLG	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 3000N-RX INACT	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 3000N-RX INACT	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 3000N-RX INACT	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 3000N-RX INACT	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 335LACKS N/C	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 335LACKS N/C	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 335LACKS N/C	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 16DIRECTIONS 3000N-RX INACT	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 16DIRECTIONS	Los Angeles District Office (LOS-DO)
9/23/2011	65GBU99PIGMENTATION AGENT N.E.C.	118NOT LISTED 16DIRECTIONS	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Takka Inter Service Co., Ltd.'s FDA import refusal history?

Takka Inter Service Co., Ltd. (FEI: 3008419342) has 16 FDA import refusal record(s) in our database, spanning from 9/23/2011 to 9/23/2011.

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. Takka Inter Service Co., Ltd.'s FEI number is 3008419342.

What types of violations has Takka Inter Service Co., Ltd. received?

Takka Inter Service 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 Takka Inter Service Co., Ltd. come from?

All FDA import refusal data for Takka Inter Service 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.