Ashiwin Fine Chemical & Pharmaceutical
⚠️ Moderate Risk
FEI: 3006130079 • Kashi Mira • INDIA
FEI Number
3006130079
Location
Kashi Mira
Country
INDIAAddress
3, Shanta Industry, , Kashi Mira, , 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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2008 | 63EAL99CARDIAC DEPRESSANT N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/9/2007 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/30/2007 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Ashiwin Fine Chemical & Pharmaceutical's FDA import refusal history?
Ashiwin Fine Chemical & Pharmaceutical (FEI: 3006130079) has 3 FDA import refusal record(s) in our database, spanning from 8/30/2007 to 8/18/2008.
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. Ashiwin Fine Chemical & Pharmaceutical's FEI number is 3006130079.
What types of violations has Ashiwin Fine Chemical & Pharmaceutical received?
Ashiwin Fine Chemical & Pharmaceutical 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 Ashiwin Fine Chemical & Pharmaceutical come from?
All FDA import refusal data for Ashiwin Fine Chemical & Pharmaceutical 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.