PT. Inhil Sarimas Kelapa
⚠️ Moderate Risk
FEI: 3008391416 • Tembilahan, Riau • INDONESIA
FEI Number
3008391416
Location
Tembilahan, Riau
Country
INDONESIAAddress
Jl Lintas Rengat-Tembilahan, , Tembilahan, Riau, 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
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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
Frequently Asked Questions
What is PT. Inhil Sarimas Kelapa's FDA import refusal history?
PT. Inhil Sarimas Kelapa (FEI: 3008391416) has 1 FDA import refusal record(s) in our database, spanning from 4/20/2009 to 4/20/2009.
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. Inhil Sarimas Kelapa's FEI number is 3008391416.
What types of violations has PT. Inhil Sarimas Kelapa received?
PT. Inhil Sarimas Kelapa has been cited for 2 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. Inhil Sarimas Kelapa come from?
All FDA import refusal data for PT. Inhil Sarimas Kelapa 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.