Daffy Healthcare Private Limited
⚠️ Moderate Risk
FEI: 3015464211 • Bangalore, Karnataka • INDIA
FEI Number
3015464211
Location
Bangalore, Karnataka
Country
INDIAAddress
Plot No 60A Sompura Industrial Area, 1st Stage Dobaspet Nelamangala Taluk, Bangalore, Karnataka, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2021 | 60QAJ67LIDOCAINE (ANESTHETIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/3/2020 | 60QDY67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 60QAJ07LIDOCAINE | Division of Southeast Imports (DSEI) | |
| 4/29/2020 | 60QBY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2020 | 60QBY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2020 | 60QBY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Daffy Healthcare Private Limited's FDA import refusal history?
Daffy Healthcare Private Limited (FEI: 3015464211) has 6 FDA import refusal record(s) in our database, spanning from 4/29/2020 to 11/10/2021.
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. Daffy Healthcare Private Limited's FEI number is 3015464211.
What types of violations has Daffy Healthcare Private Limited received?
Daffy Healthcare Private Limited has been cited for 3 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 Daffy Healthcare Private Limited come from?
All FDA import refusal data for Daffy Healthcare Private 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.