Vipor Chemicals Private Ltd.
⚠️ Moderate Risk
FEI: 3000209179 • Vadodara, Gujarat • INDIA
FEI Number
3000209179
Location
Vadodara, Gujarat
Country
INDIAAddress
301 Ivory terrace, RC Dutt Road, Vadodara, 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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/19/2018 | 60WCT34QUINACRINE HCL (ANTHELMINTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 7/24/2013 | 62LCS99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | New York District Office (NYK-DO) | |
| 6/10/2002 | 65UDS99SCLEROSING AGENT N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Vipor Chemicals Private Ltd.'s FDA import refusal history?
Vipor Chemicals Private Ltd. (FEI: 3000209179) has 3 FDA import refusal record(s) in our database, spanning from 6/10/2002 to 9/19/2018.
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. Vipor Chemicals Private Ltd.'s FEI number is 3000209179.
What types of violations has Vipor Chemicals Private Ltd. received?
Vipor Chemicals 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 Vipor Chemicals Private Ltd. come from?
All FDA import refusal data for Vipor Chemicals 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.