Hollister Medical India Private Limited
⚠️ High Risk
FEI: 3008191244 • Haryana • INDIA
FEI Number
3008191244
Location
Haryana
Country
INDIAAddress
Plot 27, Sector 5, Phase Ii Hsidc Growth Center, Bawal, Rewari, Haryana, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 4/25/2025 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hollister Medical India Private Limited's FDA import refusal history?
Hollister Medical India Private Limited (FEI: 3008191244) has 1 FDA import refusal record(s) in our database, spanning from 4/25/2025 to 4/25/2025.
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. Hollister Medical India Private Limited's FEI number is 3008191244.
What types of violations has Hollister Medical India Private Limited received?
Hollister Medical India Private Limited 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 Hollister Medical India Private Limited come from?
All FDA import refusal data for Hollister Medical India 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.