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T.C. Pharmaceutical Industries Co Ltd

⚠️ Moderate Risk

FEI: 1000304166 • Bangkok • THAILAND

FEI

FEI Number

1000304166

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

39 Moo 8 Akachai (Ekachai) Rd., Bangkhuntien, Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

47.0
LowModerateHighCritical

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

Statistics

16
Total Refusals
6
Unique Violations
10/17/2011
Latest Refusal
10/1/2001
Earliest Refusal

Score Breakdown

Violation Severity
79.5×40%
Refusal Volume
45.6×30%
Recency
0.0×20%
Frequency
15.9×10%
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

1114×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

3241×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

3281×

USUAL NAME

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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

4821×

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.

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

831×

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.

Refusal History

DateProductViolationsDivision
10/17/2011
29YET99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
64YELLOW #5
Division of West Coast Imports (DWCI)
6/2/2006
30YET99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
6/2/2006
30YCT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
7/27/2004
29YHT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
New York District Office (NYK-DO)
7/27/2004
29YHT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
New York District Office (NYK-DO)
5/14/2004
30YHT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
9/23/2003
29YHT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
324NO ENGLISH
328USUAL NAME
482NUTRIT LBL
New York District Office (NYK-DO)
11/27/2002
30YEI99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
Seattle District Office (SEA-DO)
4/17/2002
29CCT99NONALCOHOLIC BEVERAGES, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
4/17/2002
29CEE99NONALCOHOLIC BEVERAGES, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
4/17/2002
29CEE99NONALCOHOLIC BEVERAGES, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
4/16/2002
29BET99CARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
1/21/2002
29BET99CARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
1/21/2002
29BET99CARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)
12/17/2001
29YHT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
New York District Office (NYK-DO)
10/1/2001
54ACL01VITAMIN A
11UNSAFE COL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is T.C. Pharmaceutical Industries Co Ltd's FDA import refusal history?

T.C. Pharmaceutical Industries Co Ltd (FEI: 1000304166) has 16 FDA import refusal record(s) in our database, spanning from 10/1/2001 to 10/17/2011.

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. T.C. Pharmaceutical Industries Co Ltd's FEI number is 1000304166.

What types of violations has T.C. Pharmaceutical Industries Co Ltd received?

T.C. Pharmaceutical Industries 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 T.C. Pharmaceutical Industries Co Ltd come from?

All FDA import refusal data for T.C. Pharmaceutical Industries 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.