Dishman Carbogen Amcis Limited
⚠️ Moderate Risk
FEI: 1000607691 • Ahmedabad, Gujarat • INDIA
FEI Number
1000607691
Location
Ahmedabad, Gujarat
Country
INDIAAddress
1216/11 - 12 - 1216/20 - 26 Phase Iv, Gidc Estate, Ahmedabad, Gujarat, 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 Dishman Carbogen Amcis Limited's FDA import refusal history?
Dishman Carbogen Amcis Limited (FEI: 1000607691) has 3 FDA import refusal record(s) in our database, spanning from 4/8/2003 to 8/4/2014.
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. Dishman Carbogen Amcis Limited's FEI number is 1000607691.
What types of violations has Dishman Carbogen Amcis Limited received?
Dishman Carbogen Amcis Limited 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 Dishman Carbogen Amcis Limited come from?
All FDA import refusal data for Dishman Carbogen Amcis Limited 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.