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Malee Sampran Public Co. Ltd.

⚠️ Moderate Risk

FEI: 3004312873 • Sam Phran, Nakhon Pathom • THAILAND

FEI

FEI Number

3004312873

📍

Location

Sam Phran, Nakhon Pathom

🇹🇭

Country

THAILAND
🏢

Address

26, 1 Moo 5 Sampran Rd., Sam Phran, Nakhon Pathom, Thailand

Moderate Risk

FDA Import Risk Assessment

39.9
LowModerateHighCritical

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

Statistics

10
Total Refusals
6
Unique Violations
10/4/2017
Latest Refusal
12/20/2002
Earliest Refusal

Score Breakdown

Violation Severity
69.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
6.8×10%
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

838×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

627×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3211×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
10/4/2017
26ACT01COCONUT OIL, CRUDE
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
10/4/2017
21VFO48COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
10/4/2017
21VFO48COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
10/4/2017
21VFO48COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
10/4/2017
21VFO48COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
2/10/2004
29AET70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
10/27/2003
29BET10GRASS JELLY DRINK, CARBONATED
62NEEDS FCE
Los Angeles District Office (LOS-DO)
7/21/2003
32AEE99MALT BEVERAGES, N.E.C.
218LIST INGRE
320LACKS FIRM
321LACKS N/C
482NUTRIT LBL
Baltimore District Office (BLT-DO)
12/20/2002
25MFE01CARROT, JUICE OR DRINK
83NO PROCESS
Baltimore District Office (BLT-DO)
12/20/2002
21SEE24PALM NUT (PALM FRUIT, SUGAR PALM) (SUBTROPICAL AND TROPICAL FRUIT)
83NO PROCESS
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Malee Sampran Public Co. Ltd.'s FDA import refusal history?

Malee Sampran Public Co. Ltd. (FEI: 3004312873) has 10 FDA import refusal record(s) in our database, spanning from 12/20/2002 to 10/4/2017.

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. Malee Sampran Public Co. Ltd.'s FEI number is 3004312873.

What types of violations has Malee Sampran Public Co. Ltd. received?

Malee Sampran Public 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 Malee Sampran Public Co. Ltd. come from?

All FDA import refusal data for Malee Sampran Public 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.