B-Tex Ointment Mfg. Co.
⚠️ High Risk
FEI: 3002110327 • Adada, Gujarat • INDIA
FEI Number
3002110327
Location
Adada, Gujarat
Country
INDIAAddress
C - 17 Udyog Nagar, , Adada, 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
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).
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.
Refusal History
Frequently Asked Questions
What is B-Tex Ointment Mfg. Co.'s FDA import refusal history?
B-Tex Ointment Mfg. Co. (FEI: 3002110327) has 2 FDA import refusal record(s) in our database, spanning from 12/16/2016 to 5/21/2025.
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. B-Tex Ointment Mfg. Co.'s FEI number is 3002110327.
What types of violations has B-Tex Ointment Mfg. Co. received?
B-Tex Ointment Mfg. Co. 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 B-Tex Ointment Mfg. Co. come from?
All FDA import refusal data for B-Tex Ointment Mfg. Co. 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.