PT. Tonga Tiur Putra

⚠️ High Risk

FEI: 3007519436 • Cirebon, Jawa Barat • INDONESIA

FEI

FEI Number

3007519436

📍

Location

Cirebon, Jawa Barat

🇮🇩

Country

INDONESIA

🏢

Address

Pelabuhan Perikanan Kejawanan, , Cirebon, Jawa Barat, Indonesia

High Risk

FDA Import Risk Assessment

61.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/19/2012

Latest Refusal

9/15/2009

Earliest Refusal

Score Breakdown

Violation Severity

91.0×40%

Refusal Volume

52.4×30%

Recency

0.0×20%

Frequency

90.5×10%

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

Violation Summary

286018×

VETDRUGRES

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains

24914×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

29007×

CHLORAMP

The article appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of 21 U.S.C. 348.

2511×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

Refusal History

Date	Product	Violations	Division
6/19/2012	16JVO01CRAB	2900CHLORAMP	Florida District Office (FLA-DO)
6/19/2012	16JVO01CRAB	2900CHLORAMP	Florida District Office (FLA-DO)
6/19/2012	16JVO01CRAB	2900CHLORAMP	Florida District Office (FLA-DO)
6/19/2012	16JVO01CRAB	2900CHLORAMP	Florida District Office (FLA-DO)
6/19/2012	16JVO01CRAB	2900CHLORAMP	Florida District Office (FLA-DO)
6/19/2012	16JVO01CRAB	2900CHLORAMP	Florida District Office (FLA-DO)
4/6/2012	16JVO01CRAB	251POISONOUS 2900CHLORAMP	Florida District Office (FLA-DO)
6/1/2011	16JEO01CRAB	2860VETDRUGRES	New York District Office (NYK-DO)
1/19/2011	16JEO01CRAB	2860VETDRUGRES	Baltimore District Office (BLT-DO)
12/21/2010	16JEO01CRAB	2860VETDRUGRES	Baltimore District Office (BLT-DO)
12/1/2010	16JEO01CRAB	2860VETDRUGRES	Baltimore District Office (BLT-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)
9/15/2009	16JGO01CRAB	249FILTHY 2860VETDRUGRES	Florida District Office (FLA-DO)

Frequently Asked Questions

What is PT. Tonga Tiur Putra's FDA import refusal history?

PT. Tonga Tiur Putra (FEI: 3007519436) has 25 FDA import refusal record(s) in our database, spanning from 9/15/2009 to 6/19/2012.

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. PT. Tonga Tiur Putra's FEI number is 3007519436.

What types of violations has PT. Tonga Tiur Putra received?

PT. Tonga Tiur Putra has been cited for 4 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 PT. Tonga Tiur Putra come from?

All FDA import refusal data for PT. Tonga Tiur Putra 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.