Pankaja Kasturi Herbals India (P) Limited
⚠️ Moderate Risk
FEI: 3005234785 • Trivandrum, Kerala • INDIA
FEI Number
3005234785
Location
Trivandrum, Kerala
Country
INDIAAddress
Poovachal Po, , Trivandrum, Kerala, 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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2023 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/9/2023 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 3/3/2021 | 62GBA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Pankaja Kasturi Herbals India (P) Limited's FDA import refusal history?
Pankaja Kasturi Herbals India (P) Limited (FEI: 3005234785) has 3 FDA import refusal record(s) in our database, spanning from 3/3/2021 to 9/1/2023.
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. Pankaja Kasturi Herbals India (P) Limited's FEI number is 3005234785.
What types of violations has Pankaja Kasturi Herbals India (P) Limited received?
Pankaja Kasturi Herbals India (P) Limited 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 Pankaja Kasturi Herbals India (P) Limited come from?
All FDA import refusal data for Pankaja Kasturi Herbals India (P) Limited 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.