PT. Windika Utama
⚠️ High Risk
FEI: 3000255965 • Semarang, Jawa Tengah • INDONESIA
FEI Number
3000255965
Location
Semarang, Jawa Tengah
Country
INDONESIAAddress
Jln. Bringin Raya No. 37, , Semarang, Jawa Tengah, Indonesia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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:
CHLORAMP
The article appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of 21 U.S.C. 348.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2011 | 16JEO01CRAB | Baltimore District Office (BLT-DO) | |
| 4/12/2011 | 16JEO01CRAB | Baltimore District Office (BLT-DO) | |
| 4/12/2011 | 16JEO01CRAB | Baltimore District Office (BLT-DO) | |
| 4/12/2011 | 16JEO01CRAB | Baltimore District Office (BLT-DO) | |
| 4/12/2011 | 16JEO01CRAB | Baltimore District Office (BLT-DO) | |
| 4/12/2011 | 16JEO01CRAB | Baltimore District Office (BLT-DO) | |
| 2/8/2011 | 16JED01CRAB | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is PT. Windika Utama's FDA import refusal history?
PT. Windika Utama (FEI: 3000255965) has 7 FDA import refusal record(s) in our database, spanning from 2/8/2011 to 4/12/2011.
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. PT. Windika Utama's FEI number is 3000255965.
What types of violations has PT. Windika Utama received?
PT. Windika Utama 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. Windika Utama come from?
All FDA import refusal data for PT. Windika Utama 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.