PT TIGA CEMARA SENTOSA
⚠️ Moderate Risk
FEI: 3023439306 • Jakarta, Jabotabek • INDONESIA
FEI Number
3023439306
Location
Jakarta, Jabotabek
Country
INDONESIAAddress
Jln. Danau Sunter Barat 54, , Jakarta, Jabotabek, Indonesia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
Frequently Asked Questions
What is PT TIGA CEMARA SENTOSA's FDA import refusal history?
PT TIGA CEMARA SENTOSA (FEI: 3023439306) has 1 FDA import refusal record(s) in our database, spanning from 9/22/2022 to 9/22/2022.
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 TIGA CEMARA SENTOSA's FEI number is 3023439306.
What types of violations has PT TIGA CEMARA SENTOSA received?
PT TIGA CEMARA SENTOSA 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 PT TIGA CEMARA SENTOSA come from?
All FDA import refusal data for PT TIGA CEMARA SENTOSA 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.