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International Laboratories Corp., Limited

⚠️ High Risk

FEI: 3006403166 • Bang Phli, Samut Prakan • THAILAND

FEI

FEI Number

3006403166

📍

Location

Bang Phli, Samut Prakan

🇹🇭

Country

THAILAND
🏢

Address

Bangplee District, 62 Moo 8 Thanon Bang Na-Trat, Bang Phli, Samut Prakan, Thailand

High Risk

FDA Import Risk Assessment

71.4
LowModerateHighCritical

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

Statistics

27
Total Refusals
3
Unique Violations
10/16/2024
Latest Refusal
10/3/2023
Earliest Refusal

Score Breakdown

Violation Severity
75.9×40%
Refusal Volume
53.6×30%
Recency
74.9×20%
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

2725×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

22802×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
10/16/2024
53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C.
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/10/2024
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
12/19/2023
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
473LABELING
Division of Northern Border Imports (DNBI)
12/19/2023
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
473LABELING
Division of Northern Border Imports (DNBI)
11/30/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/30/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/30/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/30/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/30/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/29/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/29/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/29/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/29/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
11/29/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/3/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/3/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/3/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)
10/3/2023
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
27DRUG GMPS
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is International Laboratories Corp., Limited's FDA import refusal history?

International Laboratories Corp., Limited (FEI: 3006403166) has 27 FDA import refusal record(s) in our database, spanning from 10/3/2023 to 10/16/2024.

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. International Laboratories Corp., Limited's FEI number is 3006403166.

What types of violations has International Laboratories Corp., Limited received?

International Laboratories Corp., Limited 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 International Laboratories Corp., Limited come from?

All FDA import refusal data for International Laboratories Corp., Limited 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.