Welex Laboratories Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3003933641 • Mumbai, Maharashtra • INDIA
FEI Number
3003933641
Location
Mumbai, Maharashtra
Country
INDIAAddress
5/46 Market Building, Tardeo A/C, Mumbai, Maharashtra, 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.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
Frequently Asked Questions
What is Welex Laboratories Pvt. Ltd.'s FDA import refusal history?
Welex Laboratories Pvt. Ltd. (FEI: 3003933641) has 2 FDA import refusal record(s) in our database, spanning from 2/14/2005 to 2/3/2012.
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. Welex Laboratories Pvt. Ltd.'s FEI number is 3003933641.
What types of violations has Welex Laboratories Pvt. Ltd. received?
Welex Laboratories Pvt. Ltd. has been cited for 4 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 Welex Laboratories Pvt. Ltd. come from?
All FDA import refusal data for Welex Laboratories Pvt. 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.