Kamakhya Cosmetics & Pharmaceuticals
⚠️ Moderate Risk
FEI: 3008843233 • Guwahati • 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2011 | 53FC01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | Southwest Import District Office (SWI-DO) | |
| 5/26/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Kamakhya Cosmetics & Pharmaceuticals's FDA import refusal history?
Kamakhya Cosmetics & Pharmaceuticals (FEI: 3008843233) has 2 FDA import refusal record(s) in our database, spanning from 5/26/2011 to 5/26/2011.
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. Kamakhya Cosmetics & Pharmaceuticals's FEI number is 3008843233.
What types of violations has Kamakhya Cosmetics & Pharmaceuticals received?
Kamakhya Cosmetics & Pharmaceuticals has been cited for 4 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 Kamakhya Cosmetics & Pharmaceuticals come from?
All FDA import refusal data for Kamakhya Cosmetics & 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.