Kalbe Farma Pt
⚠️ Moderate Risk
FEI: 3008341914 • Bekasi • INDIA
FEI Number
3008341914
Location
Bekasi
Country
INDIAAddress
Ji M H Thermin Blok A3-1 Lippo, , Bekasi, , India
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is Kalbe Farma Pt's FDA import refusal history?
Kalbe Farma Pt (FEI: 3008341914) has 1 FDA import refusal record(s) in our database, spanning from 6/11/2010 to 6/11/2010.
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. Kalbe Farma Pt's FEI number is 3008341914.
What types of violations has Kalbe Farma Pt received?
Kalbe Farma Pt 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 Kalbe Farma Pt come from?
All FDA import refusal data for Kalbe Farma Pt 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.