CTX Lifesciences Private Ltd.
⚠️ Moderate Risk
FEI: 3006254924 • Surat, Gujarat • INDIA
FEI Number
3006254924
Location
Surat, Gujarat
Country
INDIAAddress
251 - 252 Plot, Sachin Magdalla Highway, Surat, 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 CTX Lifesciences Private Ltd.'s FDA import refusal history?
CTX Lifesciences Private Ltd. (FEI: 3006254924) has 1 FDA import refusal record(s) in our database, spanning from 11/8/2013 to 11/8/2013.
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. CTX Lifesciences Private Ltd.'s FEI number is 3006254924.
What types of violations has CTX Lifesciences Private Ltd. received?
CTX Lifesciences Private Ltd. 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 CTX Lifesciences Private Ltd. come from?
All FDA import refusal data for CTX Lifesciences Private Ltd. 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.