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Natthasak Saeauy

⚠️ Moderate Risk

FEI: 3011061610 • Bang Len, Nakhon Pathom • THAILAND

FEI

FEI Number

3011061610

📍

Location

Bang Len, Nakhon Pathom

🇹🇭

Country

THAILAND
🏢

Address

Moo 9, 9809 Tambol Buapaktha Amphur, Bang Len, Nakhon Pathom, Thailand

Moderate Risk

FDA Import Risk Assessment

45.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
5/26/2015
Latest Refusal
5/26/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

© ImportRefusal.com Original Analysis

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).

757×

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).

Refusal History

DateProductViolationsDivision
5/26/2015
53LY10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/26/2015
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/26/2015
54ECA99HERBALS & BOTANICAL TEAS, N.E.C.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/26/2015
53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/26/2015
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/26/2015
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/26/2015
63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Natthasak Saeauy's FDA import refusal history?

Natthasak Saeauy (FEI: 3011061610) has 7 FDA import refusal record(s) in our database, spanning from 5/26/2015 to 5/26/2015.

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. Natthasak Saeauy's FEI number is 3011061610.

What types of violations has Natthasak Saeauy received?

Natthasak Saeauy has been cited for 2 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 Natthasak Saeauy come from?

All FDA import refusal data for Natthasak Saeauy 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.