PENTA KRAFT
⚠️ Moderate Risk
FEI: 3013876156 • Haridar • INDIA
FEI Number
3013876156
Location
Haridar
Country
INDIAAddress
Plot 9, 10 & 12 Sec 3a, , Haridar, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2022 | 60ZCA99ANTIPARASITIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2021 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/24/2017 | 61WCA52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PENTA KRAFT's FDA import refusal history?
PENTA KRAFT (FEI: 3013876156) has 3 FDA import refusal record(s) in our database, spanning from 11/24/2017 to 3/25/2022.
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. PENTA KRAFT's FEI number is 3013876156.
What types of violations has PENTA KRAFT received?
PENTA KRAFT has been cited for 1 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 PENTA KRAFT come from?
All FDA import refusal data for PENTA KRAFT 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.