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SOAP-n-SCENT CO., LTD.

⚠️ High Risk

FEI: 3006553163 • Changklan, Chiangmai • THAILAND

FEI

FEI Number

3006553163

📍

Location

Changklan, Chiangmai

🇹🇭

Country

THAILAND
🏢

Address

327/9 Soi Srijundorn 2, Jareonprated Rd., Changklan, Chiangmai, Thailand

High Risk

FDA Import Risk Assessment

55.5
LowModerateHighCritical

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

Statistics

16
Total Refusals
3
Unique Violations
2/26/2010
Latest Refusal
11/3/2009
Earliest Refusal

Score Breakdown

Violation Severity
79.7×40%
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

© ImportRefusal.com Original Analysis

Violation Summary

7516×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

1614×

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.

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).

Refusal History

DateProductViolationsDivision
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/26/2010
66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/3/2009
63WBU02GREEN SOAP (DETERGENT)
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/3/2009
63WBU02GREEN SOAP (DETERGENT)
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is SOAP-n-SCENT CO., LTD.'s FDA import refusal history?

SOAP-n-SCENT CO., LTD. (FEI: 3006553163) has 16 FDA import refusal record(s) in our database, spanning from 11/3/2009 to 2/26/2010.

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. SOAP-n-SCENT CO., LTD.'s FEI number is 3006553163.

What types of violations has SOAP-n-SCENT CO., LTD. received?

SOAP-n-SCENT 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 SOAP-n-SCENT CO., LTD. come from?

All FDA import refusal data for SOAP-n-SCENT 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.