Kaya Kalp Herbals Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3003813578 • Jaipur 6, RJ • INDIA
FEI Number
3003813578
Location
Jaipur 6, RJ
Country
INDIAAddress
73 Suraj Nagar (East)Civil Lines, , Jaipur 6, RJ, 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
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.
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).
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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 |
|---|---|---|---|
| 11/3/2009 | 53QC99COSMETIC PACKAGING AND LABELING, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 11/3/2009 | 60BAY01AMMONIUM CHLORIDE (ACIDIFIER) | New Orleans District Office (NOL-DO) | |
| 11/3/2009 | 60BAY01AMMONIUM CHLORIDE (ACIDIFIER) | New Orleans District Office (NOL-DO) | |
| 11/3/2009 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 198COLOR LBLG | New Orleans District Office (NOL-DO) |
| 11/3/2009 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 197COSM COLOR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kaya Kalp Herbals Pvt. Ltd.'s FDA import refusal history?
Kaya Kalp Herbals Pvt. Ltd. (FEI: 3003813578) has 5 FDA import refusal record(s) in our database, spanning from 11/3/2009 to 11/3/2009.
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. Kaya Kalp Herbals Pvt. Ltd.'s FEI number is 3003813578.
What types of violations has Kaya Kalp Herbals Pvt. Ltd. received?
Kaya Kalp Herbals Pvt. Ltd. has been cited for 5 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 Kaya Kalp Herbals Pvt. Ltd. come from?
All FDA import refusal data for Kaya Kalp Herbals Pvt. 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.