ASHWIN FINE CHEMICALS AND PHARMACEUTICALS
⚠️ High Risk
FEI: 3012740927 • KASHIMIRA, THANE - MAHARAHSTRA • INDIA
FEI Number
3012740927
Location
KASHIMIRA, THANE - MAHARAHSTRA
Country
INDIAAddress
3, SHANTA INDL EST, OFF: W E HIGHWAY, KASHIMIRA, THANE - MAHARAHSTRA, 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).
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.
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.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
COSM MISB
The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/15/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/5/2024 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/12/2022 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 53EH99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/17/2021 | 53EH99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/31/2020 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/24/2020 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/22/2019 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/14/2019 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/18/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/4/2019 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/4/2019 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/13/2018 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 4/13/2018 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 8/9/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/28/2016 | 53EC07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/28/2016 | 53EC07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 2/10/2016 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 1/13/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/13/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/27/2014 | 66FBK99SUPPRESSANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/23/2013 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 5/22/2012 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/10/2011 | 55PG80CARAWAY (PHARMACEUTIC NECESSITY - FLAVOR) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ASHWIN FINE CHEMICALS AND PHARMACEUTICALS's FDA import refusal history?
ASHWIN FINE CHEMICALS AND PHARMACEUTICALS (FEI: 3012740927) has 25 FDA import refusal record(s) in our database, spanning from 11/10/2011 to 1/15/2025.
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. ASHWIN FINE CHEMICALS AND PHARMACEUTICALS's FEI number is 3012740927.
What types of violations has ASHWIN FINE CHEMICALS AND PHARMACEUTICALS received?
ASHWIN FINE CHEMICALS AND PHARMACEUTICALS has been cited for 11 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 ASHWIN FINE CHEMICALS AND PHARMACEUTICALS come from?
All FDA import refusal data for ASHWIN FINE CHEMICALS AND PHARMACEUTICALS 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.