Hanemann Pure Durg Pvt Ltd 13
⚠️ Moderate Risk
FEI: 3012281142 • Nozda • 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 |
|---|---|---|---|
| 10/4/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hanemann Pure Durg Pvt Ltd 13's FDA import refusal history?
Hanemann Pure Durg Pvt Ltd 13 (FEI: 3012281142) has 1 FDA import refusal record(s) in our database, spanning from 10/4/2021 to 10/4/2021.
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. Hanemann Pure Durg Pvt Ltd 13's FEI number is 3012281142.
What types of violations has Hanemann Pure Durg Pvt Ltd 13 received?
Hanemann Pure Durg Pvt Ltd 13 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 Hanemann Pure Durg Pvt Ltd 13 come from?
All FDA import refusal data for Hanemann Pure Durg Pvt Ltd 13 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.