PT. PONDAN PANGAN MAKMUR INDONESIA

⚠️ Moderate Risk

FEI: 3013133887 • Tangerang, Jabotabek • INDONESIA

FEI

FEI Number

3013133887

📍

Location

Tangerang, Jabotabek

🇮🇩

Country

INDONESIA

🏢

Address

Jalan Industri Vii Blok M No. 12, , Tangerang, Jabotabek, Indonesia

Moderate Risk

FDA Import Risk Assessment

49.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/30/2015

Latest Refusal

11/22/2006

Earliest Refusal

Score Breakdown

Violation Severity

73.5×40%

Refusal Volume

55.8×30%

Recency

0.0×20%

Frequency

34.7×10%

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

1130×

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).

27410×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

2185×

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.

2801×

UNSAFE SUB

The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.

3301×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

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.

Refusal History

Date	Product	Violations	Division
10/30/2015	03SHT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	274COLOR LBLG 330UNSAFE COL	Los Angeles District Office (LOS-DO)
10/30/2015	35CFT99CUSTARD PUDDING (PIE) MIX, N.E.C.	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
10/30/2015	35CFT99CUSTARD PUDDING (PIE) MIX, N.E.C.	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
10/30/2015	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
10/30/2015	03SHT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
10/30/2015	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
9/3/2015	35CFT99CUSTARD PUDDING (PIE) MIX, N.E.C.	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
6/18/2012	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
11/22/2009	03SFT99PREPARED DRY SWEET GOODS MIX WITHOUT CUSTARD OR CREAM FILLING N.E.C.	11UNSAFE COL 280UNSAFE SUB	Los Angeles District Office (LOS-DO)
11/22/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
11/22/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
11/22/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 274COLOR LBLG	Los Angeles District Office (LOS-DO)
11/22/2009	03SFT99PREPARED DRY SWEET GOODS MIX WITHOUT CUSTARD OR CREAM FILLING N.E.C.	11UNSAFE COL	Los Angeles District Office (LOS-DO)
11/22/2009	03SFT99PREPARED DRY SWEET GOODS MIX WITHOUT CUSTARD OR CREAM FILLING N.E.C.	11UNSAFE COL	Los Angeles District Office (LOS-DO)
10/5/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
8/28/2009	03SGT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
8/28/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
8/14/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
8/14/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
8/14/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
5/26/2009	35CET99CUSTARD PUDDING (PIE) MIX, N.E.C.	11UNSAFE COL 64YELLOW #5	Los Angeles District Office (LOS-DO)
5/26/2009	35CET99CUSTARD PUDDING (PIE) MIX, N.E.C.	11UNSAFE COL	Los Angeles District Office (LOS-DO)
5/26/2009	35AGT03AGAR AGAR (GELATIN PRODUCT)	11UNSAFE COL	Los Angeles District Office (LOS-DO)
1/9/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
1/9/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
1/9/2009	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL	Los Angeles District Office (LOS-DO)
4/11/2008	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 218LIST INGRE	Los Angeles District Office (LOS-DO)
8/8/2007	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 218LIST INGRE	Los Angeles District Office (LOS-DO)
8/8/2007	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 218LIST INGRE	Los Angeles District Office (LOS-DO)
8/8/2007	03SFT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 218LIST INGRE	Los Angeles District Office (LOS-DO)
11/22/2006	03SGT01CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	11UNSAFE COL 218LIST INGRE	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is PT. PONDAN PANGAN MAKMUR INDONESIA's FDA import refusal history?

PT. PONDAN PANGAN MAKMUR INDONESIA (FEI: 3013133887) has 31 FDA import refusal record(s) in our database, spanning from 11/22/2006 to 10/30/2015.

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. PT. PONDAN PANGAN MAKMUR INDONESIA's FEI number is 3013133887.

What types of violations has PT. PONDAN PANGAN MAKMUR INDONESIA received?

PT. PONDAN PANGAN MAKMUR INDONESIA 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 PT. PONDAN PANGAN MAKMUR INDONESIA come from?

All FDA import refusal data for PT. PONDAN PANGAN MAKMUR INDONESIA 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.