Radico
⚠️ Moderate Risk
FEI: 3001224283 • Faridabad, Haryana • INDIA
FEI Number
3001224283
Location
Faridabad, Haryana
Country
INDIAAddress
88/17 39 - A Type - D Hsidc Industrial Estate, , Faridabad, Haryana, 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
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.
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.
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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 |
|---|---|---|---|
| 3/19/2008 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/19/2008 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/24/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/16/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 1/16/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/8/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/8/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 6/16/2006 | 53FD99OTHER HAIR COLORING PREPARATIONS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 6/16/2006 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/13/2004 | 53FY01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/13/2004 | 53GH04LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | New Orleans District Office (NOL-DO) |
| 7/13/2004 | 53GH04LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Radico's FDA import refusal history?
Radico (FEI: 3001224283) has 12 FDA import refusal record(s) in our database, spanning from 7/13/2004 to 3/19/2008.
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. Radico's FEI number is 3001224283.
What types of violations has Radico received?
Radico has been cited for 7 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 Radico come from?
All FDA import refusal data for Radico 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.