Pt. Abbergummi Medical
⚠️ Moderate Risk
FEI: 1000344637 • Sidoarjo • INDONESIA
FEI Number
1000344637
Location
Sidoarjo
Country
INDONESIAAddress
Delta Sari Indah Blok AA/4, Waru, Sidoarjo, , 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
Frequently Asked Questions
What is Pt. Abbergummi Medical's FDA import refusal history?
Pt. Abbergummi Medical (FEI: 1000344637) has 2 FDA import refusal record(s) in our database, spanning from 4/21/2009 to 4/21/2009.
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. Abbergummi Medical's FEI number is 1000344637.
What types of violations has Pt. Abbergummi Medical received?
Pt. Abbergummi Medical has been cited for 1 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. Abbergummi Medical come from?
All FDA import refusal data for Pt. Abbergummi Medical 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.