Canton Laboratories Private Ltd.
⚠️ High Risk
FEI: 3003297374 • Vadodara, Gujarat • INDIA
FEI Number
3003297374
Location
Vadodara, Gujarat
Country
INDIAAddress
A & B, 110 Gidc Industrial Estate; Makarpura Road, Vadodara, Gujarat, India
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
Frequently Asked Questions
What is Canton Laboratories Private Ltd.'s FDA import refusal history?
Canton Laboratories Private Ltd. (FEI: 3003297374) has 3 FDA import refusal record(s) in our database, spanning from 3/9/2005 to 11/7/2025.
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. Canton Laboratories Private Ltd.'s FEI number is 3003297374.
What types of violations has Canton Laboratories Private Ltd. received?
Canton Laboratories Private Ltd. 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 Canton Laboratories Private Ltd. come from?
All FDA import refusal data for Canton Laboratories 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.